Cleared Traditional

RICHARD-ALLAN VESSEL LOOPS

K900566 · Richard-Allan Medical Ind., Inc. · General & Plastic Surgery
May 1990
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K900566 is an FDA 510(k) clearance for the RICHARD-ALLAN VESSEL LOOPS, a Instrument, Surgical, Disposable (Class I — General Controls, product code KDC), submitted by Richard-Allan Medical Ind., Inc. (Richland, US). The FDA issued a Cleared decision on May 3, 1990, 85 days after receiving the submission on February 7, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K900566 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1990
Decision Date May 03, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

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
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
K943229 · Y.M.K. International Co., Ltd. · Aug 1994
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