Cleared Traditional

K933767 - FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY
(FDA 510(k) Clearance)

K933767 · Mahe-Medizintechnik · Obstetrics & Gynecology device

May 1994

Decision

301d

Days

Class 1

Risk

K933767 is an FDA 510(k) clearance for the FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY. This device is classified as a Forceps, Biopsy, Gynecological (Class I - General Controls, product code HFB).

Submitted by Mahe-Medizintechnik (Nashville, US). The FDA issued a Cleared decision on May 26, 1994, 301 days after receiving the submission on July 29, 1993.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K933767 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 1993
Decision Date	May 26, 1994
Days to Decision	301 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement