Cleared Traditional

K841980 - SIDE CUTTING SERRATED BLADE
(FDA 510(k) Clearance)

K841980 · Stainless Mfg., Inc. · General & Plastic Surgery
Aug 1984
Decision
93d
Days
Class 1
Risk

K841980 is an FDA 510(k) clearance for the SIDE CUTTING SERRATED BLADE, a Instrument, Cutting, Orthopedic (Class I — General Controls, product code HTZ), submitted by Stainless Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 15, 1984, 93 days after receiving the submission on May 14, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K841980 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1984
Decision Date August 15, 1984
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HTZ — Instrument, Cutting, Orthopedic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800