Cleared Traditional

K991122 - CRYO-MONO CRYOGRNIC SYSTEM

K991122 is an FDA 510(k) clearance for CRYO-MONO CRYOGRNIC 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 90-day FDA review.

K991122 · Influence, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
90d
Days
Class 2
Risk

K991122 is an FDA 510(k) clearance for the CRYO-MONO CRYOGRNIC SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Influence, Inc. (San Francisco, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 90 days - within the typical 510(k) review window.

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: 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 Influence, Inc. devices

FDA 510(k) Submission Details - K991122

510(k) Number K991122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1999
Decision Date July 01, 1999
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 K991122.
CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE
K991792 · Influence, Inc. · Aug 1999
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
HISTOFREEZER DEVICE
K990877 · OraSure Technologies, Inc. · Jun 1999
VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
K982506 · Cryosurgery, Inc. · Jan 1999
CRYOPRO MAXI AND CRYOPRO MINI
K982280 · Cortex Technology Aps · Nov 1998