Cleared Traditional

K943046 - SKIN STAPLE REMOVAL TRAYS
(FDA 510(k) Clearance)

K943046 · Sterile Concepts, Inc. · General & Plastic Surgery

Jul 1994

Decision

32d

Days

Class 1

Risk

K943046 is an FDA 510(k) clearance for the SKIN STAPLE REMOVAL TRAYS. This device is classified as a Suture Removal Kit (Class I — General Controls, product code MCZ).

Submitted by Sterile Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on July 29, 1994, 32 days after receiving the submission on June 27, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance..

Submission Details

510(k) Number	K943046 FDA.gov
FDA Decision	Cleared SESK
Date Received	June 27, 1994
Decision Date	July 29, 1994
Days to Decision	32 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	MCZ — Suture Removal Kit
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4800
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.