Cleared Traditional

DISPOSABLE SURGICAL SCISSORS AND FORCEPS

K943229 · Y.M.K. International Co., Ltd. · General & Plastic Surgery
Aug 1994
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K943229 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL SCISSORS AND FORCEPS, a Instrument, Surgical, Disposable (Class I — General Controls, product code KDC), submitted by Y.M.K. International Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on August 19, 1994, 44 days after receiving the submission on July 6, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K943229 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1994
Decision Date August 19, 1994
Days to Decision 44 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KDC — Instrument, Surgical, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

Similar Devices — KDC Instrument, Surgical, Disposable

All 66
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
K936226 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1994
THERMUFF BAG
K920153 · Techstyles · Jul 1992
MANUAL SURGICAL INSTRUMENTS
K920263 · Phoenix Instruments Div. · May 1992
DISPOSABLE CAUTERY ABRASIVE PAD
K915064 · American Medical Mfg., Inc. · Mar 1992
INSTRUMENT ORGANIZER
K914960 · O.R. Concepts, Inc. · Feb 1992
SHUR-GRIP
K912834 · Inman Medical Corp. · Jul 1991