Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chirurgische Instrumente — 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) |
|---|---|---|---|---|---|
| K944444 | CIT BIOPSY PUNCHES | Chirurgische Instrumente | 1995-09-29 | 413 | 0 |
| K944270 | CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS | Chirurgische Instrumente | 1995-07-25 | 327 | 0 |
| K944268 | CIT TWO WAY SUCTIN AND IRRIGATION TUBES | Chirurgische Instrumente | 1995-01-26 | 147 | 0 |
| K944269 | CIT GRASPING AND DISSECTING FORCEPS | Chirurgische Instrumente | 1995-01-24 | 145 | 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