Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GAE · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950776 | BIPOLAR SNARE | Cook Urological, Inc. | 1995-04-18 | 56 | 0 |
| K926036 | ACUFEX SUTURE RETRIEVER | Acufex Microsurgical, Inc. | 1993-05-05 | 155 | 0 |
| K903174 | ADVANCE SUTURE ABSORBABLE GUT SUTURE | Advance Suture, Inc. | 1991-07-10 | 357 | 0 |
| K881224 | ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE | Acufex Microsurgical, Inc. | 1988-06-01 | 71 | 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