Cleared Traditional

GYNEX ENDOSPECULUM

K980237 · Gynex Corp. · Obstetrics & Gynecology
Apr 1998
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K980237 is an FDA 510(k) clearance for the GYNEX ENDOSPECULUM, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Gynex Corp. (Concord, US). The FDA issued a Cleared decision on April 8, 1998, 75 days after receiving the submission on January 23, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K980237 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1998
Decision Date April 08, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code KNA — Instrument, Manual, Specialized Obstetric-gynecologic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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