Atlas FDA

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

Innovative Surgical, Inc. — Predicate Candidate Screening

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

146 daysmedian FDA review time
273 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945394INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHERInnovative Surgical, Inc.1995-01-27850
K932696ISI(R) CURVED, TAPERED DISSECTING FORCEPSInnovative Surgical, Inc.1994-03-032730
K932695ISI(R) PORPOISE NOSE DISSECTING FORCEPSInnovative Surgical, Inc.1994-03-032730
K934075ISI METZENBAUM SCISSORSInnovative Surgical, Inc.1993-12-011030
K932697ISI(R) HOOK SUTURE SCISSORS, MONOPOLARInnovative Surgical, Inc.1993-11-101600
K932698ISI(R) HOOK SUTURES SCISSORSInnovative Surgical, Inc.1993-10-271460
K932534ISI FENESTRATED DISSECTING AND GRASPING FORCEPSInnovative Surgical, Inc.1993-08-19830

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