Smith & Nephew Endoscopy, Inc.
Medical device manufacturer in Andover, MA.
18510(k) clearances
0PMA approvals
0recalls
Device types
- MBI Fastener, Fixation, Nondegradable, Soft… 4
- HWC Screw, Fixation, Bone 3
- HRX Arthroscope 2
- OCW Endoscopic Tissue Approximation Device 2
- GEY Motor, Surgical Instrument, Ac-Powered 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- KGS Retention Device, Suture 1
- GAT Suture, Nonabsorbable, Synthetic… 1
- GCJ Laparoscope, General & Plastic Surgery 1
- HTN Washer, Bolt Nut 1
- MAI Fastener, Fixation, Biodegradable, Soft… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K103309 | Osteoraptor Curved 2.3 Suture AnchorsMAI · Traditional | 02/03/2011SE |
| K102660 | Bioraptor Curved 2.3 PK Suture AnchorsMBI · Traditional | 12/13/2010SE |
| K093428 | Smith & Nephew Knotless Instability AnchorMBI · Traditional | 12/17/2009SE |
| K083635 | Smith & Nephew Biosure PK Interference ScrewMBI · Traditional | 01/30/2009SE |
| K083226 | Smith & Nephew PEEK Interference ScrewMBI · Traditional | 01/30/2009SE |
| K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair DeviceHTN · Traditional | 10/21/2008SE |
| K050580 | Smith & Nephew Intelijet Fluid Management SystemsHRX · Traditional | 04/20/2005SE |
| K992396 | Biorci ScrewHWC · Traditional | 01/12/2000SE |
| K991500 | Smith & Nephew Suture LokOCW · Traditional | 07/14/1999SE |
| K972599 | Acufex Screw CannulaHWC · Traditional | 09/19/1997SE |
| K971939 | Smith & Nephew Suture ColletOCW · Traditional | 08/06/1997SE |
| K970949 | Smith & Nephew Mis InstrumentsGCJ · Traditional | 04/23/1997SE |
| K970416 | Acufex Double Armed Suture NeedleGAT · Traditional | 04/21/1997SE |
| K964935 | Suture LockKGS · Traditional | 02/25/1997SE |
| K964215 | Acufex Mosaicplasty Comprehensive SystemHRX · Traditional | 12/20/1996SE |
| K963901 | Electrosurgical ProbeGEI · Traditional | 11/04/1996SE |
| K962789 | Surgical Kit-Acufex Mosaicplasty SystemGEY · Traditional | 08/14/1996SE |
| K961649 | Acufex Tibial Anchor Screw & Spiked WasherHWC · Traditional | 07/16/1996SN |