Atlas FDA

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

Gynescope Corp. — Predicate Candidate Screening

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

70 daysmedian FDA review time
203 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902657GYNESCOPE LAPAROSCOPIC FORCEPSGynescope Corp.1990-09-19960
K902658GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODESGynescope Corp.1990-09-19960
K901530WALLACE INTRAUTERINE INSEMINATION CATHETERGynescope Corp.1990-07-231120
K902655GYNESCOPE LAPAROSCOPESGynescope Corp.1990-07-13280
K902656GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVESGynescope Corp.1990-06-29140
K902019MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPSGynescope Corp.1990-06-07350
K902049CROAK OVARIAN BIOPSY FORCEPGynescope Corp.1990-06-07310
K900878OTT INSUFFLATION FILTER TUBINGGynescope Corp.1990-05-07700
K895225GYNECOLOGICAL INSTRUMENTATIONGynescope Corp.1990-03-052030

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