Cleared Special

K031117 - SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM

K031117 is an FDA 510(k) clearance for SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, manufactured by Galil Medical , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Special 510(k) pathway after a 45-day FDA review.

K031117 · Galil Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
45d
Days
Class 2
Risk

K031117 is an FDA 510(k) clearance for the SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Galil Medical , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on May 23, 2003 after a review of 45 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Galil Medical , Ltd. devices

FDA 510(k) Submission Details - K031117

510(k) Number K031117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2003
Decision Date May 23, 2003
Days to Decision 45 days
Submission Type Special
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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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 K031117.
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
K050347 · Endocare, Inc. · Feb 2005
SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)
K042667 · Galil Medical , Ltd. · Oct 2004
CRYOCARE CS SURGICAL SYSTEM
K032333 · Endocare, Inc. · Aug 2003
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
K023487 · OraSure Technologies, Inc. · Mar 2003
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
K023757 · Endocare, Inc. · Dec 2002
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
K021261 · Galil Medical , Ltd. · Jul 2002