Cleared Traditional

K921294 - VIDEO ENDOSCOPE-RIGID MODIFICATION
(FDA 510(k) Clearance)

K921294 · Medical Dynamics, Inc. · Obstetrics & Gynecology

Jul 1994

Decision

855d

Days

Class 2

Risk

K921294 is an FDA 510(k) clearance for the VIDEO ENDOSCOPE-RIGID MODIFICATION. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET).

Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on July 20, 1994, 855 days after receiving the submission on March 17, 1992.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number	K921294 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1992
Decision Date	July 20, 1994
Days to Decision	855 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement