Cleared Traditional

K050347 - MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM

K050347 is an FDA 510(k) clearance for MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM, manufactured by Endocare, Inc.. The device is a Class 2 Radiology device with product code GEH cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K050347 · Endocare, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
14d
Days
Class 2
Risk

K050347 is an FDA 510(k) clearance for the MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Endocare, Inc. (Irvin, US). The FDA issued a Cleared decision on February 25, 2005 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4350 - the FDA radiology and imaging software oversight 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 Endocare, Inc. devices

FDA 510(k) Submission Details - K050347

510(k) Number K050347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2005
Decision Date February 25, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Radiology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 230
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K050347.
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
K052861 · Sanarus Medical, Inc. · Nov 2005
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
K051509 · Erbe USA, Inc. · Jul 2005
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
K051052 · Galil Medical , Ltd. · May 2005
SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)
K042667 · Galil Medical , Ltd. · Oct 2004
POLAR WAND
K041783 · Chek-Med Systems · Sep 2004
CRYOCARE CS SURGICAL SYSTEM
K032333 · Endocare, Inc. · Aug 2003