Cleared Traditional

K931425 - SURGICAL PATCH SPREADER

K931425 is an FDA 510(k) clearance for SURGICAL PATCH SPREADER, manufactured by General Surgical Innovations. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K931425 · General Surgical Innovations · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
337d
Days
Class 2
Risk

K931425 is an FDA 510(k) clearance for the SURGICAL PATCH SPREADER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by General Surgical Innovations (Portola Valley, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 337 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 General Surgical Innovations devices

FDA 510(k) Submission Details - K931425

510(k) Number K931425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date February 22, 1994
Days to Decision 337 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 115d · This submission: 337d
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 914
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K931425.
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
K926479 · Davol, Inc. · Mar 1994
SENSING TIP SURGICAL TROCAR
K930848 · Origin Medsystems, Inc. · Mar 1994
PUNCTURE CLOSURE DEVICE
K934807 · Advanced Surgical, Inc. · Mar 1994
STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
K934094 · Stryker Corp. · Feb 1994
LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE
K932540 · Advanced Surgical, Inc. · Feb 1994
5,6,7,9,10,11&12MM BLUNT-TIPPED TROCAR OBTURATORS
K934511 · Phx Technologies Corp. · Feb 1994