Cleared Traditional

K920283 - DISPOSABLE SKIN STAPLE REMOVER

K920283 is an FDA 510(k) clearance for DISPOSABLE SKIN STAPLE REMOVER, manufactured by Trinity Laboratories, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MCZ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K920283 · Trinity Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
121d
Days
Class 1
Risk

K920283 is an FDA 510(k) clearance for the DISPOSABLE SKIN STAPLE REMOVER. Classified as Suture Removal Kit (product code MCZ), Class I - General Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on May 22, 1992 after a review of 121 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K920283

510(k) Number K920283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1992
Decision Date May 22, 1992
Days to Decision 121 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
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 7
Devices cleared under the same product code (MCZ) and FDA review panel - the closest regulatory comparables to K920283.
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
SUTURE REMOVAL KIT, STERILE, DISPOSABLE
K920280 · Trinity Laboratories, Inc. · May 1992
SUTURE REMOVAL KIT
K910361 · Megadyne Medical Products, Inc. · Mar 1991
STERILE SUTURE REMOVAL KIT
K812132 · E.M. Adams · Dec 1981