Cleared Traditional

K812132 - STERILE SUTURE REMOVAL KIT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K812132 · E.M. Adams · General & Plastic Surgery device
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Dec 1981
Decision
126d
Days
Class 1
Risk

K812132 is an FDA 510(k) clearance for the STERILE SUTURE REMOVAL KIT. Classified as Suture Removal Kit (product code MCZ), Class I - General Controls.

Submitted by E.M. Adams (Mchenry, US). The FDA issued a Cleared decision on December 1, 1981 after a review of 126 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 E.M. Adams devices

Submission Details

510(k) Number K812132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1981
Decision Date December 01, 1981
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 114d · This submission: 126d
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.