Smith & Nephew Inc., Endoscopy Div.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Smith & Nephew Inc., Endoscopy Div.” (first 2007, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 | 1 | 84 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Smith & Nephew Inc., Endoscopy Div. took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 3 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 | 3 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | 1 | 1 |
Review panels
- Orthopedic (7)
- General Hospital (3)
Most recent Smith & Nephew Inc., Endoscopy Div. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242631 | REGENETEN Bioinductive Implant | OWY | 2024-11-26 | 84 |
| K111843 | ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM | OLO | 2011-11-14 | 138 |
| K102544 | SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY | KCT | 2011-01-05 | 124 |
| K092551 | SMITH & NEPHEW INSTRUMENT TRAYS | KCT | 2010-09-14 | 390 |
| K100159 | SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR | MBI | 2010-04-19 | 89 |
| K093943 | BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM | MBI | 2010-03-05 | 73 |
| K093897 | SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR | MBI | 2010-03-04 | 76 |
| K073551 | SMITH & NEPHEW INSTRUMENT TRAYS | KCT | 2008-05-21 | 155 |
| K080358 | PLLA, HA SCREW | HWC | 2008-04-23 | 72 |
| K063726 | PLC SUTURE ANCHOR | HRS | 2007-03-06 | 81 |
Recalls
12 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2015-09-10.
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. (547 510(k)s)
- Smith & Nephew Richards, Inc. (87 510(k)s)
- Smith & Nephew United, Inc. (34 510(k)s)
- Smith & Nephew Dyonics, Inc. (22 510(k)s)
- Smith & Nephew Medical Limited (20 510(k)s)
- Smith & Nephew Endoscopy, Inc. (18 510(k)s)
- Smith and Nephew Donjoy, Inc. (15 510(k)s)
- Smith & Nephew Medical, Ltd. (12 510(k)s)
- Smith River Biologicals (12 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith & Nephew Inc., Endoscopy Div.?
FDA lists 10 510(k) clearances under the applicant name “Smith & Nephew Inc., Endoscopy Div.” (first 2007, latest 2024), across 6 product codes in 2 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 Inc., Endoscopy Div.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew Inc., Endoscopy Div. is 86 days.
Which FDA product codes appear under Smith & Nephew Inc., Endoscopy Div.?
The most frequent FDA product codes under this applicant name are KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 3); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 3); HRS (Plate, Fixation, Bone, 1).
Next steps
- See all 10 Smith & Nephew Inc., Endoscopy Div. clearances with predicates and recalls
- Run predicate analysis for product code KCT, Smith & Nephew Inc., Endoscopy Div.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.