Forceps
FDA product code HTD · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
73510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Kinetic Medical Products 14
- Imm Enterprises , Ltd. 14
- The Huxley Instrument Corp. 9
- Arthropedics, Inc. 8
- Titan Mfg., Inc. 3
- Solway, Inc. 2
- Conphar, Inc. 2
- Almore Intl., Inc. 2
- Cimed Intl., Inc. 2
- Artiberia 2
- Sterling Multi-Products, Inc. 1
- E.D.Medical , Ltd. 1
- Link America, Inc. 1
- Bowen & Company, Inc. 1
- Medtech Industries, Inc. 1
- Depuy, Inc. 1
- New England Surgical Instrument Corp. 1
- Zimmer, Inc. 1
- Acufex Microsurgical, Inc. 1
- Dravon Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051281 | The Needle CatcherHTD · Traditional | E.D.Medical , Ltd. | 09/08/2005SE |
| K974595 | Cushing Bayonet, Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974594 | Semkin Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974593 | Semkin Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K913964 | Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional | Marlo Surgical Technology | 10/23/1991SE |
| K911180 | Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K895212 | Tik ExtraktorHTD · Traditional | Instruments of Sweden, Inc. | 09/27/1989SE |
| K890373 | Hemorrhoidal ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890369 | Gall Stone ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890263 | Cilia ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890262 | Lung ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890260 | Bone ShearsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890259 | Rib ShearsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890258 | Bone Cutting Forceps, Single-ActionHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890257 | Bone Cutting Forceps, Double-ActionHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890246 | Artery ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890244 | Tubing Clamp ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890238 | Catheter ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890234 | Suture Clip RemoverHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890226 | Surgical ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890213 | Microsurgical ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K874965 | Manual Surgical Instruments for General UseHTD · Traditional | Solway, Inc. | 12/30/1987SE |
| K874950 | Microsurgical InstrumentsHTD · Traditional | Solway, Inc. | 12/30/1987SE |
| K874023 | Levtech Clamp ApplierHTD · Traditional | Levtech, Inc. | 11/06/1987SE |
| K873513 | Serrated Grasping Forceps, Curved UpHTD · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873512 | Serrated Grasping Forceps, RightHTD · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873511 | Serrated Grasping Forceps, LeftHTD · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873510 | Serrated Grasping Forceps, Curved DownHTD · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873506 | Cup Biopsy Forceps, Curved UpHTD · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873505 | Cup Biopsy Forceps, Curved DownHTD · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873504 | Cup Biopsy Forceps, RightHTD · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873503 | Cup Biopsy Forceps, LeftHTD · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K871535 | Smiljanic Bone Repositioning ForcepsHTD · Traditional | Link America, Inc. | 05/14/1987SE |
| K870881 | Loose Body GraspersHTD · Traditional | Bowen & Company, Inc. | 03/23/1987SE |
| K852729 | Aalstead Mosq. Forceps, Straight, 5+SS 410 or 420HTD · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852728 | Kelly Hemostatic Forceps, Straight 5-1/2+SSHTD · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852727 | Rochester - Pean Forceps, Straight, 6-1/4+SSHTD · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852723 | Foerster Sponge Forceps, Serrated, 7+SS 410 or 420HTD · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852722 | Sterilizing Forceps, 3-PRONGE, 11+SS 410 or 420HTD · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852720 | Thumb Dressing Forceps, 5+SS 410 or 420HTD · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852718 | Adson Tissue Forceps, 1X2 Teeth 4-3/4+SSHTD · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852715 | Magill Forceps, Adult, 10 + SS 410 or 420HTD · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852713 | Russian Tissue Forceps, 6 + SS 410 or 420HTD · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K851770 | Various Dressing Tissue Froceps(Gillies, Jeans, RaHTD · Traditional | Artiberia | 06/20/1985SE |
| K851769 | Various Dressing/Tissue Forceps(English, Thumb, TRHTD · Traditional | Artiberia | 06/20/1985SE |
| K842819 | Hook Punch Forceps for ArthroscopyHTD · Traditional | Medtech Industries, Inc. | 08/14/1984SE |
| K834367 | Suture Removal Wound Closure-Instru-HTD · Traditional | Sterling Multi-Products, Inc. | 05/30/1984SE |
| K840304 | Category 17-MICROBIOLOGY DevicesHTD · Traditional | Imm Enterprises , Ltd. | 05/01/1984SE |
| K840766 | Janacek Tubo-Uterine Implantation SetHTD · Traditional | Cimed Intl., Inc. | 04/23/1984SE |
| K840318 | Cat. 14-CLINICAL Toxiology DevicesHTD · Traditional | Imm Enterprises , Ltd. | 04/23/1984SE |
| K840320 | Cat. 16-IMMUNOLOGY DevicesHTD · Traditional | Imm Enterprises , Ltd. | 03/12/1984SE |
| K840319 | Cat 15-HEMATOLOGY & Pathology DeviceHTD · Traditional | Imm Enterprises , Ltd. | 03/12/1984SE |
| K840317 | Cat 13-CLINICAL Chemistry DevicesHTD · Traditional | Imm Enterprises , Ltd. | 03/12/1984SE |
| K840316 | Cat 12-ORTHOPEDIC & Rehab DeviceHTD · Traditional | Imm Enterprises , Ltd. | 03/12/1984SE |
| K840315 | Cat 11- General & Plastic Surgery DevHTD · Traditional | Imm Enterprises , Ltd. | 03/12/1984SE |
| K840309 | Cat. 5-RADIOLOGY DevicesHTD · Traditional | Imm Enterprises , Ltd. | 03/12/1984SE |
| K840307 | Cat. 3 Gastroenterology-Urology DevHTD · Traditional | Imm Enterprises , Ltd. | 03/12/1984SE |
| K840306 | Category 2 Gen. Hospital & Personal UseHTD · Traditional | Imm Enterprises , Ltd. | 03/12/1984SE |
| K833629 | Certain Manual Surg. Instru. AccessHTD · Traditional | Cimed Intl., Inc. | 01/30/1984SE |
| K834542 | H.R. Jakobi Surg. Instru. Sect. 48HTD · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K834185 | Jakobi Surg. Instruments #11 14/45HTD · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K834183 | H.R. Jakobi Surg. Instruments #11 25/39HTD · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K834180 | H.R. Jakobi Surg. Instruments #11 13/20HTD · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K831138 | Curved Hemostat 5HTD · Traditional | Almore Intl., Inc. | 05/18/1983SE |
| K831137 | Straight 5 HemostatHTD · Traditional | Almore Intl., Inc. | 05/18/1983SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | Conphar, Inc. | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | Conphar, Inc. | 05/28/1982SE |
| K820344 | Rowe Shoulder Instr. for Bankhart RepairHTD · Traditional | New England Surgical Instrument Corp. | 03/08/1982SE |
| K802676 | Orhtopedic Reamer 87 HTDHTD · Traditional | Zimmer, Inc. | 11/12/1980SE |
| K800273 | Acufex ForcepsHTD · Traditional | Acufex Microsurgical, Inc. | 02/19/1980SE |
| K771097 | Forcep, Disp., a ClampHTD · Traditional | Dravon Medical, Inc. | 07/14/1977SE |
| K771192 | Lowman Bone ForcepHTD · Traditional | Edward Weck, Inc. | 07/11/1977SE |
| K770206 | Grasping ForcepsHTD · Traditional | Depuy, Inc. | 02/08/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1310-2025 Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps…The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Aesculap Inc | 01/31/2025Open, Classified |
| Z-0940-2025 Class II | ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-1554-2022 Class II | NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701The sterile barrier may be compromised. | Stradis Medical, LLC dba Stradis Healthcare | 07/25/2022Open, Classified |
| Z-1553-2022 Class II | NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700The sterile barrier may be compromised. | Stradis Medical, LLC dba Stradis Healthcare | 07/25/2022Open, Classified |
| Z-1035-2019 Class II | Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are…An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | ConvaTec, Inc | 01/09/2019Open, Classified |
| Z-0680-2019 Class II | GEM Coupler Forceps, GEM4183C, packaged individually.Potential presence of rust on Coupler Forceps (GEM4183C). | Baxter Healthcare Corporation | 11/02/2018Open, Classified |
| Z-0523-2014 Class II | outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use…Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm… | Biomet, Inc. | 11/26/2013Terminated |
| Z-0560-2014 Class III | Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip.…Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors… | Edwards Lifesciences, LLC | 11/20/2013Terminated |
| Z-0077-2010 | SYNTHES PLATE HOLDING FORCEPS, Catalog # SD347.900The recalling firm has determined that the customized plates instruments do not have a cleared premarket… | Synthes USA (HQ), Inc. | 09/03/2009Terminated |
| Z-0075-2010 | SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix…The recalling firm has determined that the customized plates instruments do not have a cleared premarket… | Synthes USA (HQ), Inc. | 09/03/2009Terminated |
| Z-0268-2008 | Pilling Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws, Catalog…The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage… | Telefelx Medical | 10/31/2007Terminated |
| Z-0267-2008 | Pilling Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog…The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage… | Telefelx Medical | 10/31/2007Terminated |
| Z-0266-2008 | Pilling Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog…The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage… | Telefelx Medical | 10/31/2007Terminated |
| Z-0539-2010 | Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000…The tips of the forceps were larger than the positioning holes located on the trials and the implant liners. | Stryker Howmedica Osteonics Corp. | 01/24/2007Terminated |