Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgeons Choice, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
87 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851122 | PI-PNEUMO INTESTINAL STAPLING CARTRIDGE | Surgeons Choice, Inc. | 1985-04-25 | 37 | 0 |
| K851121 | PI-PHEUMO INTESTINAL INSTRUMENT SET | Surgeons Choice, Inc. | 1985-04-25 | 37 | 0 |
| K843399 | SURGEONS CHOICE PI VASCULAR STAPLING | Surgeons Choice, Inc. | 1984-11-05 | 67 | 0 |
| K830768 | DISPOSABLE SKIN STAPLER | Surgeons Choice, Inc. | 1983-04-12 | 32 | 0 |
| K823776 | PI-PNEUMO-INTESTINAL INSTRUMENT SET | Surgeons Choice, Inc. | 1983-01-14 | 30 | 0 |
| K813170 | ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER | Surgeons Choice, Inc. | 1982-02-12 | 87 | 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