Cleared Traditional

K895774 - GYN-PROBE

K895774 is an FDA 510(k) clearance for GYN-PROBE, manufactured by Trimedyne, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K895774 · Trimedyne, Inc. · General & Plastic Surgery device
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Jan 1990
Decision
99d
Days
Class 2
Risk

K895774 is an FDA 510(k) clearance for the GYN-PROBE. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Trimedyne, Inc. (Tustin, US). The FDA issued a Cleared decision on January 3, 1990 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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. Standard predicate reliance. 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 Trimedyne, Inc. devices

FDA 510(k) Submission Details - K895774

510(k) Number K895774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date January 03, 1990
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 - GEX Powered Laser Surgical Instrument

All 1566
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K895774.
KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY
K896183 · Laserscope · Feb 1990
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K896847 · Sharplan Lasers, Inc. · Jan 1990
35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM
K896049 · Pfizer Laser Systems · Jan 1990
OPTILASE YAG MODEL 1000
K895874 · Trimedyne, Inc. · Jan 1990
STERILE DISPOSABLE INFRATIP
K895918 · Heraeus Lasersonics, Inc. · Dec 1989
SITE 810E PHOTOCOAGULATOR AND ACCESSORIES
K895663 · Site Microsurgical Systems, Inc. · Dec 1989