Cleared Traditional

K925015 - STERILE SUTURE REMOVAL KIT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K925015 · Customed, Inc. · General & Plastic Surgery device
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Jun 1993
Decision
256d
Days
Class 1
Risk

K925015 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 Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on June 7, 1993 after a review of 256 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 Customed, Inc. devices

Submission Details

510(k) Number K925015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 24, 1992
Decision Date June 07, 1993
Days to Decision 256 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
142d slower than avg
Panel avg: 114d · This submission: 256d
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.