Cleared Traditional

K991517 - CRYO-HIT II

K991517 is an FDA 510(k) clearance for CRYO-HIT II, manufactured by Galil Medical , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K991517 · Galil Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
88d
Days
Class 2
Risk

K991517 is an FDA 510(k) clearance for the CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Galil Medical , Ltd. (Washington, US). The FDA issued a Cleared decision on July 27, 1999 after a review of 88 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 Galil Medical , Ltd. devices

FDA 510(k) Submission Details - K991517

510(k) Number K991517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1999
Decision Date July 27, 1999
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 128
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K991517.
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · Endocare, Inc. · Nov 2000
SEEDNET, MODEL EP6T5, EP5E5
K003065 · Galil Medical , Ltd. · Oct 2000
CRYO-HIT
K993965 · Galil Medical , Ltd. · Feb 2000
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
HISTOFREEZER DEVICE
K982358 · OraSure Technologies, Inc. · Oct 1998