Smith & Nephew Inc., Endoscopy Division: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Smith & Nephew Inc., Endoscopy Division” (first 2007, latest 2013), across 5 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 | 1 | 255 |
| 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 | 3 | 3 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 1 | 1 |
Review panels
- Orthopedic (7)
- General Hospital (1)
Most recent Smith & Nephew Inc., Endoscopy Division 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121904 | GYNECOLOGY STERILIZATION TRAY | KCT | 2013-03-11 | 255 |
| K102982 | ENDOBUTTON DIRECT | MAI | 2011-01-05 | 90 |
| K082215 | OSTEORAPTOR SUTURE ANCHOR | JDR | 2008-11-03 | 89 |
| K081098 | ENDOBUTTON CONTINUOUS LOOP (CL) | JDR | 2008-07-16 | 90 |
| K072785 | TWINFIX FT PK | HWC | 2007-12-10 | 70 |
| K071586 | BIORAPTOR 2.3 PK SUTURE ANCHOR | MBI | 2007-08-17 | 67 |
| K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR | MBI | 2007-05-16 | 44 |
| K070167 | ENDOBUTTON DIRECT | MBI | 2007-04-12 | 84 |
Recalls
128 product recalls in 31 recall events; 0 initiated in the last five years. Most recent: 2014-06-02.
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 & Nephew Endoscopy, Inc. (18 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith & Nephew Inc., Endoscopy Division?
FDA lists 8 510(k) clearances under the applicant name “Smith & Nephew Inc., Endoscopy Division” (first 2007, latest 2013), across 5 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 Division?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew Inc., Endoscopy Division is 86 days.
Which FDA product codes appear under Smith & Nephew Inc., Endoscopy Division?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 3); JDR (Staple, Fixation, Bone, 2); HWC (Screw, Fixation, Bone, 1).
Next steps
- See all 8 Smith & Nephew Inc., Endoscopy Division clearances with predicates and recalls
- Run predicate analysis for product code MBI, Smith & Nephew Inc., Endoscopy Division'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.