Forceps, General & Plastic Surgery
FDA product code GEN · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
104510(k) clearances
0PMA approvals
8recalls
Manufacturers
- Conphar, Inc. 14
- The Huxley Instrument Corp. 8
- Mill-Rose Laboratory 6
- Artiberia 6
- Edward Weck, Inc. 5
- Solos Endoscopy, Inc. 4
- Sea-Pac Trading Corp. 3
- Orthopedic Equipment Co., Inc. 3
- Arthropedics, Inc. 2
- Medcare Products 2
- C. Intl. 2
- Acme United Corp. 2
- I-Tech Industries, Inc. 2
- Zinnanti Surgical Instruments, Inc. 2
- Eder Instrument Co, Inc. 1
- Surgical Technology Laboratories, Inc. 1
- Medline Industries, LP 1
- Dravon Medical, Inc. 1
- Focus Medical, LLC 1
- J. Jamner Surgical Instruments, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031828 | Naturalase LP Nd:Yag LaserGEN · Traditional | Focus Medical, LLC | 07/17/2003SE |
| K953962 | ForcepsGEN · Traditional | Biopsys Medical, Inc. | 09/08/1995SE |
| K932385 | Suture Removing ForcepsGEN · Traditional | Rocket of London, Ltd. | 08/06/1993SE |
| K904723 | ForcepsGEN · Traditional | Minto Research & Development, Inc. | 07/26/1991SE |
| K911159 | Palpation ProbeGEN · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K900960 | GS-1500 Claw Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900952 | GS-1200 Grasping/Extracting Forcep, 10MMGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900951 | GS-7000 Clip-Applying Forcep, 10MM, Medium ClipGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900948 | GS-1002 Grasping Forcep, 5MM with RatchetGEN · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K891896 | Tissue Forceps, Various TypesGEN · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891401 | Hemostatic Forceps Bruns.,Gemini,Spencer-Well,KantGEN · Traditional | Zinnanti Surgical Instruments, Inc. | 04/06/1989SE |
| K891348 | Campion Laser ForcepsGEN · Traditional | Simpson/Basye, Inc. | 03/22/1989SE |
| K884514 | Forceps, Towel, Backhaus-Tsk (Brand) TowelGEN · Traditional | Gatewood and Associates, Ltd. | 11/17/1988SE |
| K884181 | Manual Surgical Instruments (Several Models)GEN · Traditional | Sales & Marketing Assoc. | 11/10/1988SE |
| K884195 | General Surgical Instruments (Various Types)GEN · Traditional | Mumtaz I. Malik | 10/24/1988SE |
| K875319 | NSN #6515-00-690-3209 Debakey Tissue ForcepsGEN · Traditional | I-Tech Industries, Inc. | 01/22/1988SE |
| K874634 | NSN #6515-00-333-2400 Adson Dressing ForcepsGEN · Traditional | I-Tech Industries, Inc. | 12/02/1987SE |
| K873978 | Disposable Bipolar ForcepsGEN · Traditional | E.M. Adams | 11/23/1987SE |
| K872991 | Micrins Forceps 2010GEN · Traditional | Micrins Surgical, Inc. | 08/17/1987SE |
| K872271 | Various Sizes & Styles of Monopolar ForcepsGEN · Traditional | New England Surgical Instrument Corp. | 06/26/1987SE |
| K871927 | Cup Biopsy Forcep, 1.7MMGEN · Traditional | Arthropedics, Inc. | 06/09/1987SE |
| K871926 | Grasping Forcep, 1.7MMGEN · Traditional | Arthropedics, Inc. | 06/09/1987SE |
| K864608 | Adobe Enterprises Surgical/Bandage Scissors ForcepGEN · Traditional | Adobe Ent. | 12/16/1986SE |
| K861805 | Medcare Forceps (Thumb, Tissue)GEN · Traditional | Medcomp Technologies, Inc. | 05/23/1986SE |
| K854916 | Pilling Hemostatic Clip Applier ForcepsGEN · Traditional | Pilling Co. | 01/24/1986SE |
| K854541 | Tip Off ForcepsGEN · Traditional | Keller Instruments, Inc. | 12/17/1985SE |
| K854146 | Surgical & Dental InstrumentGEN · Traditional | Baort, Inc. | 11/13/1985SE |
| K853153 | Medus GmbHGEN · Traditional | Corkes Medical Co. | 08/07/1985SE |
| K853015 | Self-Centering Bone Holding Forceps, 10-1/4 SS420GEN · Traditional | The Huxley Instrument Corp. | 07/29/1985SE |
| K852730 | Crile Forceps, Striaght, 6-1/4+SS 410 or 420GEN · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852717 | Iris Forceps, Delicate, 1X2 Teeth, Straight, 4XSSGEN · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852120 | Forceps, Biopsy(Non Rigid)GEN · Traditional | Scholten Surgical Instruments, Inc. | 07/02/1985SE |
| K851728 | 2250/1 to 2285/2 Various Cotton TweezersGEN · Traditional | Artiberia | 07/01/1985SE |
| K852531 | Non-Perforating Towel FORCEPS-5-1/4 in SS 410GEN · Traditional | The Huxley Instrument Corp. | 06/28/1985SE |
| K851796 | 51-210 to 51-352 Various Intest for Callis, LockwoGEN · Traditional | Artiberia | 06/20/1985SE |
| K851793 | 39-260 to 39-299 Various Foreign Body ForcepsGEN · Traditional | Artiberia | 06/20/1985SE |
| K851773 | 17-280,17-576 Haemostatic Forceps Spenceruells, KiGEN · Traditional | Artiberia | 06/20/1985SE |
| K851772 | 17-100,17-272 Various Haemostatic ForcepsGEN · Traditional | Artiberia | 06/20/1985SE |
| K851771 | 15-490 to 15-520 Various Splinter Forceps Peet, STGEN · Traditional | Artiberia | 06/20/1985SE |
| K851673 | Raka Och Bosda PeangerGEN · Traditional | General Electric Trading Co. | 05/29/1985SE |
| K851170 | Dissecting Tweezer #283-72PCS. SS 410GEN · Traditional | The Huxley Instrument Corp. | 04/25/1985SE |
| K851116 | Judd-Aillis Tissue Forceps 1820-118 Pcs. SS 410/42GEN · Traditional | The Huxley Instrument Corp. | 04/25/1985SE |
| K851114 | Magill Forceps 1711-46 Pcs. SS 410 or 420GEN · Traditional | The Huxley Instrument Corp. | 04/25/1985SE |
| K851106 | Pratt-Smith T Forceps 1830-40 Pcs. SS 420 or 420FGEN · Traditional | The Huxley Instrument Corp. | 04/25/1985SE |
| K844062 | Forceps & HamostatsGEN · Traditional | I M, Inc. | 01/18/1985SE |
| K843074 | Dispos. & Sponge Forceps Pean ArteryGEN · Traditional | Greene International Corp. | 08/17/1984SE |
| K834095 | Biopsy ForcepsGEN · Traditional | Micro Vasive, Inc. | 01/27/1984SE |
| K833542 | Surgical InstrumentGEN · Traditional | Hirata Sangyo Co. USA, Inc. | 11/28/1983SE |
| K831805 | General Surgical InstrumentsGEN · Traditional | Aim Corp. | 07/14/1983SE |
| K822591 | Tissue ForcepsGEN · Traditional | Medcare Products | 10/13/1982SE |
| K822491 | Disposable Grasping ForcepsGEN · Traditional | Van-Tec, Inc. | 09/17/1982SE |
| K822278 | ENT ForcepsGEN · Traditional | Kelleher Corp. | 08/27/1982SE |
| K821248 | Rochester Pean ForcepsGEN · Traditional | Conphar, Inc. | 05/28/1982SE |
| K821353 | Conphar Allis ForcepsGEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821339 | Salmonella PolyGEN · Traditional | Analytical Products, Inc. | 05/27/1982SE |
| K821296 | Rochester Pean Forceps Curved 6 1/4GEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821287 | Crile Forceps Straight 5 1/2GEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821283 | Hartman Forceps (Mosquito)GEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821281 | Crile, Curved Forceps 5 1/2GEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821280 | Tissue ForcepsGEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821279 | Halstead Forceps (Mosquito) 5GEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821278 | Hartman Forceps Straight 3 1/2GEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821277 | Kelly Forceps Curved 5 1/2GEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821274 | Halstead Mosquito ForcepsGEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821267 | Thumb Dressing ForcepsGEN · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821349 | Conphar Foerster ForcepsGEN · Traditional | Conphar, Inc. | 05/25/1982SE |
| K821288 | Tube Occulding Forceps 7GEN · Traditional | Conphar, Inc. | 05/25/1982SE |
| K821143 | Disposable Thumb ForcepsGEN · Traditional | Medcare Products | 05/21/1982SE |
| K820980 | Biopsy Forceps W/Oval Cup & NeedleGEN · Traditional | Mill-Rose Laboratory | 04/26/1982SE |
| K820972 | Biopsy Forceps W/Oval CupsGEN · Traditional | Mill-Rose Laboratory | 04/26/1982SE |
| K820970 | Retrieval Forceps W/Rattoothed JawsGEN · Traditional | Mill-Rose Laboratory | 04/26/1982SE |
| K820969 | Biopsy Forcepw W/Small Oval CupsGEN · Traditional | Mill-Rose Laboratory | 04/26/1982SE |
| K820968 | Retrieval Forceps W/Alligator JawsGEN · Traditional | Mill-Rose Laboratory | 04/26/1982SE |
| K820967 | Biopsy Forceps W/Alligator Type CupsGEN · Traditional | Mill-Rose Laboratory | 04/26/1982SE |
| K813245 | O'Connor Hook Punch ForcepGEN · Traditional | Shutt Instruments | 12/29/1981SE |
| K812785 | Vance-Ambrose Resectoscope ForcepsGEN · Traditional | Vance Products, Inc. | 11/16/1981SE |
| K812205 | ForcepGEN · Traditional | Reznik Instruments | 10/26/1981SE |
| K811686 | Surgical InstrumentsGEN · Traditional | C.V.I., Inc. | 07/20/1981SE |
| K810685 | Suture Removal KitGEN · Traditional | Medical Action Industries, Inc. | 03/26/1981SE |
| K801991 | Plastic Forceps CAT.#1001-1010GEN · Traditional | Pollak (Intl.), Ltd. | 09/16/1980SE |
| K801075 | Straith Chisel ForcepsGEN · Traditional | Surgical Technology Laboratories, Inc. | 05/20/1980SE |
| K800647 | Norsen DebriderGEN · Traditional | Medline Industries, Inc. | 04/16/1980SE |
| K800435 | Hemostatic/Tube Occluding ForcepsGEN · Traditional | Dravon Medical, Inc. | 03/12/1980SE |
| K792494 | Catheterization ForcepGEN · Traditional | C. Intl. | 12/20/1979SE |
| K792309 | Castroviejo Vascular Needleholder 538425GEN · Traditional | Edward Weck, Inc. | 11/30/1979SE |
| K792100 | Grasping Forcep (W/Four Prongs)GEN · Traditional | Eder Instrument Co, Inc. | 11/13/1979SE |
| K791987 | Vascular Forceps & ClampsGEN · Traditional | Edward Weck, Inc. | 10/04/1979SE |
| K790854 | Forceps #101 and #102GEN · Traditional | C. Intl. | 06/05/1979SE |
| K781448 | Harrington Hook ClampGEN · Traditional | Orthopedic Equipment Co., Inc. | 09/27/1978SE |
| K781447 | Threaded Rod ClampGEN · Traditional | Orthopedic Equipment Co., Inc. | 09/27/1978SE |
| K781446 | C Ring ClincherGEN · Traditional | Orthopedic Equipment Co., Inc. | 09/27/1978SE |
| K772393 | Carroll Tendon RetrieverGEN · Traditional | Edward Weck, Inc. | 05/09/1978SE |
| K772383 | Long Jewelers ForcepsGEN · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K771515 | Suture Tissue Approximating ForcepGEN · Traditional | United States Surgical, A Division of Tyco Healthc | 09/30/1977SE |
| K771746 | ForcepsGEN · Traditional | Depuy, Inc. | 09/26/1977SE |
| K771691 | Angled Forcep ApplierGEN · Traditional | Edward Weck, Inc. | 09/22/1977SE |
| K771624 | Cope Lung Forceps #305-218GEN · Traditional | J. Jamner Surgical Instruments, Inc. | 09/06/1977SE |
| K770540 | Forceps, Mosquito Style, 12.5 Cm.GEN · Traditional | Sea-Pac Trading Corp. | 04/15/1977SE |
| K770539 | Forceps, Haem, Deep Operation, 20&22 Cm.GEN · Traditional | Sea-Pac Trading Corp. | 04/15/1977SE |
| K770538 | Forceps, Haemostatic, 14 16,&18 Cm. LongGEN · Traditional | Sea-Pac Trading Corp. | 04/15/1977SE |
| K770329 | Womb Prep KitGEN · Traditional | American Hospital Supply Corp. | 04/05/1977SE |
| K761334 | Marcuse Tube Clamping Forceps, StraightGEN · Traditional | J. Sklar Mfg. Co., Inc. | 02/24/1977SE |
| K760507 | Forcep, ThumbGEN · Traditional | Acme United Corp. | 11/12/1976SE |
| K760703 | Sponge and Gauze Forcep Part #S-417-9GEN · Traditional | Acme United Corp. | 10/21/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0939-2025 Class II | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-0757-2025 Class II | STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | MEDLINE INDUSTRIES, LP - Northfield | 11/12/2024Open, Classified |
| Z-0756-2025 Class II | ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | MEDLINE INDUSTRIES, LP - Northfield | 11/12/2024Open, Classified |
| Z-1437-2024 Class II | Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-0237-2019 Class II | Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN…Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units | Micro-Tech (Nanjing) Co., Ltd. | 09/20/2018Terminated |
| Z-0751-2017 Class II | Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic…The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the… | Integra York PA, Inc | 10/28/2016Terminated |
| Z-1629-2013 Class II | - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | Surgical Instrument Service And Savings, Inc. | 05/03/2013Terminated |
| Z-2392-2010 | BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25") (L), STAINLESS…The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used. | Biomet Microfixation, Inc. | 06/25/2010Terminated |