Cleared Traditional

A.C.S. SUTURE REMOVAL KIT (K915827) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K915827 · American Carolina Stamping · General & Plastic Surgery device
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Dec 1992
Decision
344d
Days
Class 1
Risk

K915827 is an FDA 510(k) clearance for the A.C.S. SUTURE REMOVAL KIT. Classified as Suture Removal Kit (product code MCZ), Class I - General Controls.

Submitted by American Carolina Stamping (Etowah, US). The FDA issued a Cleared decision on December 8, 1992 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K915827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 30, 1991
Decision Date December 08, 1992
Days to Decision 344 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
229d slower than avg
Panel avg: 115d · This submission: 344d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.