Cleared Traditional

K964827 - PROD. NO. 01-132 - SUTURE REMOVAL KIT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K964827 · Continental Medical Laboratories, Inc. · General & Plastic Surgery device
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Feb 1997
Decision
74d
Days
Class 1
Risk

K964827 is an FDA 510(k) clearance for the PROD. NO. 01-132 - SUTURE REMOVAL KIT. Classified as Suture Removal Kit (product code MCZ), Class I - General Controls.

Submitted by Continental Medical Laboratories, Inc. (Waterford, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Continental Medical Laboratories, Inc. devices

Submission Details

510(k) Number K964827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1996
Decision Date February 14, 1997
Days to Decision 74 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
40d faster than avg
Panel avg: 114d · This submission: 74d
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.