Cleared Traditional

K872386 - C CLAMP
(FDA 510(k) Clearance)

K872386 · Med-Tool, Inc. · General & Plastic Surgery device

Jul 1987

Decision

13d

Days

Class 1

Risk

K872386 is an FDA 510(k) clearance for the C CLAMP. This device is classified as a Clamp (Class I - General Controls, product code HXD).

Submitted by Med-Tool, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 2, 1987, 13 days after receiving the submission on June 19, 1987.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K872386 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 19, 1987
Decision Date	July 02, 1987
Days to Decision	13 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—