Cleared Traditional

K850423 - CONCEPT SUCTION SLEEVE
(FDA 510(k) Clearance)

K850423 · Concept, Inc. · General & Plastic Surgery

Mar 1985

Decision

38d

Days

Class 1

Risk

K850423 is an FDA 510(k) clearance for the CONCEPT SUCTION SLEEVE, a Instrument, Cutting, Orthopedic (Class I — General Controls, product code HTZ), submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 14, 1985, 38 days after receiving the submission on February 4, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K850423 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 1985
Decision Date	March 14, 1985
Days to Decision	38 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—