Smith & Nephew Endoscopy, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Smith & Nephew Endoscopy, Inc.” (first 1996, latest 2011), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Smith+Nephew, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 4 | 4 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| HRX | Arthroscope | 2 | 2 |
| OCW | Endoscopic Tissue Approximation Device | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 | 1 |
| HTN | Washer, Bolt Nut | 1 | 1 |
| KGS | Retention Device, Suture | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Smith & Nephew Endoscopy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103309 | OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS | MAI | 2011-02-03 | 85 |
| K102660 | BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS | MBI | 2010-12-13 | 89 |
| K093428 | SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR | MBI | 2009-12-17 | 44 |
| K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW | MBI | 2009-01-30 | 53 |
| K083226 | SMITH & NEPHEW PEEK INTERFERENCE SCREW | MBI | 2009-01-30 | 88 |
| K082095 | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE | HTN | 2008-10-21 | 89 |
| K050580 | SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS | HRX | 2005-04-20 | 44 |
| K992396 | BIORCI SCREW | HWC | 2000-01-12 | 177 |
| K991500 | SMITH & NEPHEW SUTURE LOK | OCW | 1999-07-14 | 76 |
| K972599 | ACUFEX SCREW CANNULA | HWC | 1997-09-19 | 67 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Smith & Nephew Endoscopy, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Smith & Nephew, Inc. (556 510(k)s)
- Smith & Nephew Richards, Inc. (87 510(k)s)
- Smith & Nephew United, Inc. (34 510(k)s)
- Smith & Nephew Medical Limited (30 510(k)s)
- Smith & Nephew Dyonics, Inc. (22 510(k)s)
- Smith and Nephew Donjoy, Inc. (15 510(k)s)
- Smith River Biologicals (12 510(k)s)
- Smith & Nephew Inc., Endoscopy Div. (10 510(k)s)
- Smith & Nephew, Inc., Orthopaedic Div. (10 510(k)s)
- Smith & Nephew Perry (10 510(k)s)
- Smith & Nephew, Mpl Division (9 510(k)s)
- Smith & Nephew Inc., Endoscopy Division (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith & Nephew Endoscopy, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Smith & Nephew Endoscopy, Inc.” (first 1996, latest 2011), across 11 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Smith & Nephew Endoscopy, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew Endoscopy, Inc. is 74 days.
Which FDA product codes appear under Smith & Nephew Endoscopy, Inc.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 4); HWC (Screw, Fixation, Bone, 3); HRX (Arthroscope, 2).
Next steps
- See all 18 Smith & Nephew Endoscopy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Smith & Nephew Endoscopy, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.