Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Via Surgical , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203117 | TissueTak device | Via Surgical , Ltd. | 2021-01-07 | 83 | 0 |
| K181668 | FasTouch Absorbable Fixation System | Via Surgical , Ltd. | 2019-03-13 | 261 | 0 |
| K162252 | FasTouch Fixation System | Via Surgical , Ltd. | 2016-11-14 | 96 | 0 |
| K132698 | FASTOUCH FIXATION SYSTEM | Via Surgical , Ltd. | 2014-03-14 | 197 | 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