Cleared Traditional

K932281 - VERRES NEEDLE

K932281 is an FDA 510(k) clearance for VERRES NEEDLE, manufactured by Surgeon Surgical Instrumentation, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K932281 · Surgeon Surgical Instrumentation, Inc. · Gastroenterology & Urology device
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Aug 1993
Decision
86d
Days
Class 2
Risk

K932281 is an FDA 510(k) clearance for the VERRES NEEDLE. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Surgeon Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on August 6, 1993 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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.

FDA 510(k) Submission Details - K932281

510(k) Number K932281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1993
Decision Date August 06, 1993
Days to Decision 86 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 131d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCT Device Classification - Class 2, Special Controls

Product Code GCT Light Source, Endoscope, Xenon Arc
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCT Light Source, Endoscope, Xenon Arc

All 46
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K932281.
COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE
K933405 · Cogent Light Technologies, Inc. · Feb 1994
COOL LIGHT 300
K935423 · Endosurgical Development Corp. · Jan 1994
ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
K933868 · Angiolaz, Inc. · Nov 1993
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
K924897 · Medical Devices, Inc. · Jul 1993
PENTAX XENON LIGHT SOURCE
K921315 · Pentax Precision Instrument Corp. · Jun 1993
SYSTEM 3000 XENON VIDEOLAP LIGHT
K923210 · Cabot Medical Corp. · Oct 1992
K932281 · VERRES NEEDLE
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