Cleared Traditional

K052530 - SEEDNET

K052530 is an FDA 510(k) clearance for SEEDNET, 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 65-day FDA review.

K052530 · Galil Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
65d
Days
Class 2
Risk

K052530 is an FDA 510(k) clearance for the SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA. 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 November 18, 2005 after a review of 65 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 - K052530

510(k) Number K052530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2005
Decision Date November 18, 2005
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
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 K052530.
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
K060390 · Galil Medical , Ltd. · Apr 2006
CRYOCARE CS SURGICAL SYSTEM
K060279 · Endocare, Inc. · Feb 2006
SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
K060144 · Galil Medical , Ltd. · Feb 2006
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
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
K050347 · Endocare, Inc. · Feb 2005