Cleared Traditional

GYNESURG

K780587 · Polamedco, Inc. · Obstetrics & Gynecology
May 1978
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K780587 is an FDA 510(k) clearance for the GYNESURG, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Polamedco, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1978, 44 days after receiving the submission on April 11, 1978. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K780587 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1978
Decision Date May 25, 1978
Days to Decision 44 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

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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