Cleared Traditional

K802599 - ARTHROSCOPIC FAT PAD RETRACTOR (FDA 510(k) Clearance)

Oct 1980
Decision
10d
Days
Class 1
Risk

K802599 is an FDA 510(k) clearance for the ARTHROSCOPIC FAT PAD RETRACTOR. This device is classified as a Retractor (Class I - General Controls, product code GAD).

Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980, 10 days after receiving the submission on October 21, 1980.

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

Submission Details

510(k) Number K802599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1980
Decision Date October 31, 1980
Days to Decision 10 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GAD — Retractor
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800