Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Surgical Devices, A Division of Tyco Healthcare · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE | Surgical Devices, A Division of Tyco Healthcare | 2010-05-10 | 102 | 1 |
| K100242 | AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER | Surgical Devices, A Division of Tyco Healthcare | 2010-02-17 | 21 | 0 |
| K093408 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | Surgical Devices, A Division of Tyco Healthcare | 2009-11-12 | 10 | 1 |
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