MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS— 510(k) K902019

Substantially Equivalent

Gynescope Corp.

FDA 510(k) clearance K902019 for MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS, Substantially Equivalent on 1990-06-07. Applicant: Gynescope Corp..

Clearance details

Applicant: Gynescope Corp.
Product code: Code HDF
Advisory panel: Obstetrics/Gynecology
Date received: 1990-05-03
Decision date: 1990-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willoughby, OH, US

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Adverse events under product code HDF

product code HDF

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.