Cleared Traditional

K924834 - PREMIERE STERILE SUTURE REMOVAL KIT(HC-...

K924834 is an FDA 510(k) clearance for PREMIERE STERILE SUTURE REMOVAL KIT(HC-..., manufactured by American Healthcare Supply Co., Inc.. The device is a Class 1 General & Plastic Surgery device with product code MCZ cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K924834 · American Healthcare Supply Co., Inc. · General & Plastic Surgery device
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Mar 1993
Decision
179d
Days
Class 1
Risk

K924834 is an FDA 510(k) clearance for the PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957). Classified as Suture Removal Kit (product code MCZ), Class I - General Controls.

Submitted by American Healthcare Supply Co., Inc. (South Plainfield, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 179 days - an extended review 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: 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 American Healthcare Supply Co., Inc. devices

FDA 510(k) Submission Details - K924834

510(k) Number K924834 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 25, 1992
Decision Date March 23, 1993
Days to Decision 179 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 115d · This submission: 179d
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 K924834.
AMSINO SUTURE REMOVAL KIT
K050656 · Amsino International, Inc. · May 2005
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
DISPOSABLE SKIN STAPLE REMOVER
K920283 · Trinity Laboratories, Inc. · May 1992
SUTURE REMOVAL KIT, STERILE, DISPOSABLE
K920280 · Trinity Laboratories, Inc. · May 1992