Cleared Traditional

K964827 - PROD. NO. 01-132 - SUTURE REMOVAL KIT

K964827 is an FDA 510(k) clearance for PROD. NO. 01-132 - SUTURE REMOVAL KIT, manufactured by Continental Medical Laboratories, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MCZ cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K964827 · Continental Medical Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K964827

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 115d · This submission: 74d
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 9
Devices cleared under the same product code (MCZ) and FDA review panel - the closest regulatory comparables to K964827.
AMSINO SUTURE REMOVAL KIT
K050656 · Amsino International, Inc. · May 2005
GRAND MEDICAL SUTURE REMOVAL KIT
K963714 · Grand Medical Products · Nov 1996
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