Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Gabris Surgical Corp. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

27 daysmedian FDA review time
234 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954774SHIELDED TROCAR (OBTURATOR)Gabris Surgical Corp.1996-06-072340
K953548LAPAROSCOPIC SURGICAL INSTRUMENTGabris Surgical Corp.1995-09-19530
K944640LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KITGabris Surgical Corp.1994-10-11200
K944104GABRIS LAPAROSCOPIC SURGICAL KITSGabris Surgical Corp.1994-09-13210
K944103LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTGabris Surgical Corp.1994-09-12200
K943989LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENTGabris Surgical Corp.1994-09-12270
K930716LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATIONGabris Surgical Corp.1993-07-231620

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