Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith & Nephew Inc., Endoscopy Division — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
255 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121904 | GYNECOLOGY STERILIZATION TRAY | Smith & Nephew Inc., Endoscopy Division | 2013-03-11 | 255 | 0 |
| K102982 | ENDOBUTTON DIRECT | Smith & Nephew Inc., Endoscopy Division | 2011-01-05 | 90 | 0 |
| K082215 | OSTEORAPTOR SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Division | 2008-11-03 | 89 | 9 |
| K081098 | ENDOBUTTON CONTINUOUS LOOP (CL) | Smith & Nephew Inc., Endoscopy Division | 2008-07-16 | 90 | 0 |
| K072785 | TWINFIX FT PK | Smith & Nephew Inc., Endoscopy Division | 2007-12-10 | 70 | 0 |
| K071586 | BIORAPTOR 2.3 PK SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Division | 2007-08-17 | 67 | 1 |
| K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Division | 2007-05-16 | 44 | 0 |
| K070167 | ENDOBUTTON DIRECT | Smith & Nephew Inc., Endoscopy Division | 2007-04-12 | 84 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda