Cleared Traditional

K812389 - SURGICAL LOOPS
(FDA 510(k) Clearance)

K812389 · Berkeley Medevices · General & Plastic Surgery device

Nov 1981

Decision

88d

Days

Class 1

Risk

K812389 is an FDA 510(k) clearance for the SURGICAL LOOPS. This device is classified as a Retractor (Class I - General Controls, product code GAD).

Submitted by Berkeley Medevices (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981, 88 days after receiving the submission on August 20, 1981.

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

Submission Details

510(k) Number	K812389 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 20, 1981
Decision Date	November 16, 1981
Days to Decision	88 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—