Cleared Traditional

K943046 - SKIN STAPLE REMOVAL TRAYS

K943046 is an FDA 510(k) clearance for SKIN STAPLE REMOVAL TRAYS, manufactured by Sterile Concepts, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MCZ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K943046 · Sterile Concepts, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
32d
Days
Class 1
Risk

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

Submitted by Sterile Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on July 29, 1994 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sterile Concepts, Inc. devices

FDA 510(k) Submission Details - K943046

510(k) Number K943046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

MCZ Device Classification - Class 1, General Controls

Product Code MCZ Suture Removal Kit
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MCZ Suture Removal Kit

All 10
Devices cleared under the same product code (MCZ) and FDA review panel - the closest regulatory comparables to K943046.
AMSINO SUTURE REMOVAL KIT
K050656 · Amsino International, Inc. · May 2005
PROD. NO. 01-132 - SUTURE REMOVAL KIT
K964827 · Continental Medical Laboratories, Inc. · Feb 1997
GRAND MEDICAL SUTURE REMOVAL KIT
K963714 · Grand Medical Products · Nov 1996
CARAPACE INCISION AND DRAINAGE TRAYS
K931597 · Carapace, Inc. · Nov 1993
STERILE SUTURE REMOVAL KIT
K925015 · Customed, Inc. · Jun 1993
SUTURE REMOVAL KIT
K922339 · Transidyne General Corp. · Dec 1992