Instrument, Surgical, Disposable
FDA product code KDC · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
67510(k) clearances
0PMA approvals
15recalls
Manufacturers
- Euro-Med Intl. 7
- Instranetics, Inc. 5
- Medcare Products 4
- Omega-Med Intl., Inc. 4
- Devon Industries, Inc. 3
- Ormed Mfg., Inc. 2
- Axiom Medical, Inc. 2
- G.D. Searle and Co. 2
- Medical Engineering Corp. 1
- Mick Radio-Nuclear Instruments, Inc. 1
- Acme United Corp. 1
- Rowley Mfg. Co. 1
- Sil-Med Corp. 1
- Aeroceuticals 1
- Y.M.K. International Co., Ltd. 1
- Kmi Medical, Inc. 1
- Medicare Industries, Inc. 1
- Abbott Laboratories 1
- Ransom and Randolph 1
- Med General 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943229 | Disposable Surgical Scissors and ForcepsKDC · Traditional | Y.M.K. International Co., Ltd. | 08/19/1994SE |
| K936226 | Surgimed Breast Localization Needle Wire SetKDC · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 03/07/1994SE |
| K920153 | Thermuff BagKDC · Traditional | Techstyles | 07/01/1992SE |
| K920263 | Manual Surgical InstrumentsKDC · Traditional | Phoenix Instruments Div. | 05/06/1992SE |
| K915064 | Disposable Cautery Abrasive PadKDC · Traditional | American Medical Mfg., Inc. | 03/11/1992SE |
| K914960 | Instrument OrganizerKDC · Traditional | O.R. Concepts, Inc. | 02/28/1992SE |
| K912834 | Shur-GripKDC · Traditional | Inman Medical Corp. | 07/26/1991SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | Applied Vascular Devices, Inc. | 02/27/1991SE |
| K905240 | VesseloopsKDC · Traditional | Sparta Surgical Corp. | 02/06/1991SE |
| K903649 | Bradley Tenaculum HolderKDC · Traditional | Marlo Surgical Technology | 11/02/1990SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | Richard-Allan Medical Ind., Inc. | 05/03/1990SE |
| K896676 | Key Vascular LoopsKDC · Traditional | Key Surgical, Inc. | 02/27/1990SE |
| K854901 | Pacific GrasperKDC · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K854898 | Atlantic GrasperKDC · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K854897 | Max-I-GraspKDC · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K854896 | Hook ScissorKDC · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K854895 | Basket ForcepKDC · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K854894 | SpoonKDC · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K854890 | Hook ProbeKDC · Traditional | Euro-Med Intl. | 05/02/1986SE |
| K853597 | Instrument Makar Disposalbe LoopKDC · Traditional | Instrument Makar, Inc. | 09/23/1985SE |
| K832441 | Suture-Aid BootiesKDC · Traditional | Omega-Med Intl., Inc. | 03/05/1984SE |
| K833355 | SDC Vascular TiesKDC · Traditional | Science Development Corp. | 01/27/1984SE |
| K831118 | Pmt-Optica LineKDC · Traditional | Pmt, Inc. | 01/25/1984SE |
| K832680 | Micro-Edge Disposable BladesKDC · Traditional | Micromedics, Inc. | 10/14/1983SE |
| K830800 | C-LoopsKDC · Traditional | Concept, Inc. | 10/04/1983SE |
| K831842 | Dravon T ClampKDC · Traditional | Dravon Medical, Inc. | 09/26/1983SE |
| K831915 | Safety Pins & Rubber BandsKDC · Traditional | Ormed Mfg., Inc. | 09/12/1983SE |
| K831911 | Disposable Floor InstrumentsKDC · Traditional | Ormed Mfg., Inc. | 09/12/1983SE |
| K831665 | Disposable Needle HolderKDC · Traditional | Medcare Products | 09/12/1983SE |
| K831664 | Plastic Thumb ForcepsKDC · Traditional | Medcare Products | 09/12/1983SE |
| K831661 | Disposable ScissorsKDC · Traditional | Medcare Products | 08/25/1983SE |
| K831798 | Disposable ScalpelsKDC · Traditional | I M, Inc. | 07/19/1983SE |
| K831662 | Disposable Hemostat (Straight&CurvedKDC · Traditional | Medcare Products | 07/19/1983SE |
| K830248 | Devo'N LoopsKDC · Traditional | Devon Industries, Inc. | 03/08/1983SE |
| K830326 | Negative Pressure Arterial Blood LineKDC · Traditional | Erika, Inc. | 02/28/1983SE |
| K822065 | Kam SuckerKDC · Traditional | The Anspach Effort, Inc. | 08/16/1982SE |
| K821166 | Kolor Kode TMKDC · Traditional | Devon Industries, Inc. | 05/13/1982SE |
| K820638 | Pediatric SuckerKDC · Traditional | 3M Health Care, Sarns | 04/09/1982SE |
| K820161 | Axiom Lig-A-BootsKDC · Traditional | Axiom Medical, Inc. | 03/15/1982SE |
| K820158 | Olsen #770 Disposable HolsterKDC · Traditional | Olsen Electro-Surgical Instruments, Inc. | 02/05/1982SE |
| K811824 | Cautery Caddy PadKDC · Traditional | Instranetics, Inc. | 07/20/1981SE |
| K811823 | Sharps Caddy FBKDC · Traditional | Instranetics, Inc. | 07/20/1981SE |
| K811822 | Tip-VuKDC · Traditional | Instranetics, Inc. | 07/20/1981SE |
| K811712 | Tip WipeKDC · Traditional | Devon Industries, Inc. | 07/20/1981SE |
| K811303 | AltracludeKDC · Traditional | R&H Medical, Inc. | 06/16/1981SE |
| K811280 | Flex-TemplateKDC · Traditional | Mick Radio-Nuclear Instruments, Inc. | 06/02/1981SE |
| K811191 | Davis & Geck Needle/Sharps CounterKDC · Traditional | Davis & Geck, Inc. | 05/27/1981SE |
| K811120 | Surgical Staple RemoverKDC · Traditional | Acme United Corp. | 05/05/1981SE |
| K810883 | Omed Silicone Instrument CoversKDC · Traditional | Omega-Med Intl., Inc. | 04/23/1981SE |
| K810785 | Skin Staple RemoverKDC · Traditional | Rowley Mfg. Co. | 04/10/1981SE |
| K810080 | Vascular Tie (Vas-Tie)KDC · Traditional | Sil-Med Corp. | 04/02/1981SE |
| K810269 | Omed Fabric Instrument CoversKDC · Traditional | Omega-Med Intl., Inc. | 02/26/1981SE |
| K810260 | Omed Silicone LoopsKDC · Traditional | Omega-Med Intl., Inc. | 02/26/1981SE |
| K802485 | Searle Vascular LoopsKDC · Traditional | G.D. Searle and Co. | 02/12/1981SE |
| K810112 | SWR Disposable Prep RazorKDC · Traditional | G.D. Searle and Co. | 02/04/1981SE |
| K803156 | Surgitek Medi-LoopsKDC · Traditional | Medical Engineering Corp. | 01/15/1981SE |
| K802895 | Cobe Centry 2 Variable CONCENTRATE-18-KDC · Traditional | Cobe Laboratories, Inc. | 12/22/1980SE |
| K802865 | Safe T CountKDC · Traditional | Instranetics, Inc. | 12/18/1980SE |
| K802866 | Sharps Caddy Magnetic & Sharps Caddy FoaKDC · Traditional | Instranetics, Inc. | 11/17/1980SE |
| K801908 | SI-14KDC · Traditional | Kmi Medical, Inc. | 11/12/1980SE |
| K800015 | Axiom Vessel LoopsKDC · Traditional | Axiom Medical, Inc. | 03/25/1980SE |
| K791434 | Sponge Counter BagsKDC · Traditional | Medicare Industries, Inc. | 10/09/1979SE |
| K780880 | Y-Type Blood SetKDC · Traditional | Abbott Laboratories | 06/30/1978SE |
| K780399 | Instrument Cleaning BrushKDC · Traditional | Ransom and Randolph | 03/17/1978SE |
| K771702 | Vessel-StabilizerKDC · Traditional | Med General | 12/13/1977SE |
| K770794 | Suture Removal Set, SterileKDC · Traditional | Lukens Corp. | 05/06/1977SE |
| K760362 | Lancet, Blood, Sterile Stainless SteelKDC · Traditional | Aeroceuticals | 09/13/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1766-2025 Class II | Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395Three is the potential for the retractors to puncture through the sterile packaging. | MEDLINE INDUSTRIES, LP - Northfield | 04/09/2025Open, Classified |
| Z-1441-2024 Class II | Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256)…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-0765-2023 Class II | Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247…Scissors contained debris. | Medical Action Industries, Inc. 306 | 10/12/2022Terminated |
| Z-1946-2021 Class II | Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or… | Medical Action Industries, Inc. 306 | 05/11/2021Terminated |
| Z-1945-2021 Class II | Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or… | Medical Action Industries, Inc. 306 | 05/11/2021Terminated |
| Z-2889-2016 Class II | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or…ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber… | Ethicon, Inc. | 08/01/2016Terminated |
| Z-2027-2011 | Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110…There is a potential for the air filter at the distal end of the set to become detached. This could result… | Hospira Inc. | 03/28/2011Terminated |
| Z-2026-2011 | Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 99 Inch with Drip…There is a potential for the air filter at the distal end of the set to become detached. This could result… | Hospira Inc. | 03/28/2011Terminated |
| Z-2025-2011 | Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 100 Inch with Clave and…There is a potential for the air filter at the distal end of the set to become detached. This could result… | Hospira Inc. | 03/28/2011Terminated |
| Z-2024-2011 | Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing…There is a potential for the air filter at the distal end of the set to become detached. This could result… | Hospira Inc. | 03/28/2011Terminated |
| Z-2250-2010 | REF 9906, DIGIT TRAP FINGER GRASPING DEVICE, STERILE. CONMED LINVATEC, 11311 CONCEPT…This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that… | Linvatec Corp. dba ConMed Linvatec | 01/28/2010Terminated |
| Z-2249-2010 | REF 9903, DIGIT TRAP FINGER GRASPING DEVICE, LARGE STERILE. CONMED LINVATEC, 11311…This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that… | Linvatec Corp. dba ConMed Linvatec | 01/28/2010Terminated |
| Z-0730-2008 | Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State…Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21 needle… | Tri-State Hospital Supply Corporation | 10/26/2007Terminated |
| Z-0701-2007 | SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog…Incorrectly assembled by manufacturer | Scanlan International Inc | 02/19/2007Terminated |
| Z-0596-2007 | JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The…The JariTrak Table Clamp may not securely fasten to the bed rail of the OR table during set up of the… | J. Jamner Surgical Instruments, Inc. | 11/14/2006Terminated |