Cleared Traditional

K991792 - CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE

K991792 is an FDA 510(k) clearance for CRYO-MONO CRYOGENIC SYSTEM, manufactured by Influence, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K991792 · Influence, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
78d
Days
Class 2
Risk

K991792 is an FDA 510(k) clearance for the CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Influence, Inc. (Washington, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Influence, Inc. devices

FDA 510(k) Submission Details - K991792

510(k) Number K991792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1999
Decision Date August 12, 1999
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
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 - GEH Unit, Cryosurgical, Accessories

All 200
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K991792.
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · Endocare, Inc. · Nov 2000
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K003065 · Galil Medical , Ltd. · Oct 2000
CRYO-HIT
K993965 · Galil Medical , Ltd. · Feb 2000
CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
K991517 · Galil Medical , Ltd. · Jul 1999
CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E
K991272 · Galil Medical , Ltd. · Jul 1999
CRYO-MONO CRYOGRNIC SYSTEM
K991122 · Influence, Inc. · Jul 1999