Cleared Traditional

K102006 - CRYOMEGA

K102006 is an FDA 510(k) clearance for CRYOMEGA, manufactured by Stc Consulting, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K102006 · Stc Consulting, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
82d
Days
Class 2
Risk

K102006 is an FDA 510(k) clearance for the CRYOMEGA. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Stc Consulting, LLC (Allentown, US). The FDA issued a Cleared decision on October 6, 2010 after a review of 82 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.

FDA 510(k) Submission Details - K102006

510(k) Number K102006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2010
Decision Date October 06, 2010
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
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 249
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K102006.
ATRICURE CRYO MODULE
K111042 · AtriCure, Inc. · May 2011
CRYONIZE TM
K103310 · 3jt Enterprises, LLC · Feb 2011
ICESENCE 3
K102360 · IceCure Medical , Ltd. · Nov 2010
CRYOBALLOON ABLATION SYSTEM
K101825 · C2 Therapeutics · Sep 2010
CRYOCARE CS SURGICAL SYSTEM
K101333 · Endocare, Inc. · Jun 2010
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
K091721 · New Medical Technologies GmbH · Oct 2009
K102006 · CRYOMEGA
Download PDF FDA Summary Stc Consulting, LLC