Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Medical Endoscopy, Inc. · 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) |
|---|---|---|---|---|---|
| K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | 2026-06-04 | 258 | 0 |
| K260271 | Strauss Surgical cystoscope, hysteroscope and accessories In | American Medical Endoscopy, Inc. | 2026-03-27 | 58 | 0 |
| K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AS | American Medical Endoscopy, Inc. | 2025-08-01 | 64 | 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