Cleared Traditional

K925959 - FORCEPS FOR LAPAROSCOPIC SURGERY GU USE

K925959 is the FDA 510(k) clearance for FORCEPS FOR LAPAROSCOPIC SURGERY GU USE by Zinnanti Surgical Instruments, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K925959 · Zinnanti Surgical Instruments, Inc. · General & Plastic Surgery device
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Nov 1993
Decision
353d
Days
Class 2
Risk

K925959 is an FDA 510(k) clearance for the FORCEPS FOR LAPAROSCOPIC SURGERY GU USE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on November 12, 1993 after a review of 353 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 Zinnanti Surgical Instruments, Inc. devices

Submission Details

510(k) Number K925959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1992
Decision Date November 12, 1993
Days to Decision 353 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
238d slower than avg
Panel avg: 115d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 693
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K925959.
TROCAR W/CANNULA, O RING, ADAPTER, AND ADAPTER SLEEVE MODIFICATION
K934534 · Baxter Healthcare Corp · Dec 1993
PHX TECHNOLOGIES CORP., IRRIGATION SOLUTION DELIVERY SYSTEM, ISDS-1000
K934076 · Phx Technologies Corp. · Nov 1993
PHX TECHNOLOGIES CORP., ISDS-2000, IRRIGATION SOLUTION DELIVERY SYSTEM
K934725 · Phx Technologies Corp. · Nov 1993
NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE
K926016 · Zinnanti Surgical Instruments, Inc. · Nov 1993
MICROWAVE INSURG INTRODUCER
K933985 · Boston Scientific Corp · Nov 1993
COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE
K933456 · Conmedcorp · Nov 1993