Cleared Traditional

K841979 - 4MM CUP CURRETTE
(FDA 510(k) Clearance)

K841979 · Stainless Mfg., Inc. · General & Plastic Surgery device
Jun 1984
Decision
36d
Days
Class 1
Risk

K841979 is an FDA 510(k) clearance for the 4MM CUP CURRETTE. This device is classified as a Curette (Class I - General Controls, product code HTF).

Submitted by Stainless Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984, 36 days after receiving the submission on May 14, 1984.

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

Submission Details

510(k) Number K841979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date June 19, 1984
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HTF — Curette
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800