Cleared Traditional

K925382 - CUTTER, SURGICAL

K925382 is an FDA 510(k) clearance for CUTTER, manufactured by Mectra Laboratories, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K925382 · Mectra Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
315d
Days
Class 2
Risk

K925382 is an FDA 510(k) clearance for the CUTTER, SURGICAL. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Mectra Laboratories, Inc. (Bloomfield, US). The FDA issued a Cleared decision on September 3, 1993 after a review of 315 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 876.1500 - 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.

View all Mectra Laboratories, Inc. devices

FDA 510(k) Submission Details - K925382

510(k) Number K925382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1992
Decision Date September 03, 1993
Days to Decision 315 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
200d slower than avg
Panel avg: 115d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1155
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K925382.
ENDOSCOPE ACCESSORY
K931895 · Applied Medical Resources · Sep 1993
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
K932976 · Cabot Medical Corp. · Sep 1993
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
K932977 · Cabot Medical Corp. · Sep 1993
SURGICAL RETRACTOR/BLUNT DISSECTOR
K933009 · Advanced Surgical, Inc. · Sep 1993
SRUGICAL RETRACTOR, MODIFICATION
K933049 · Advanced Surgical, Inc. · Aug 1993
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE
K931518 · Imagyn Medical, Inc. · Aug 1993