Cleared Special

K010991 - SEEDNET, MODELS FP6T5, FP5T5, FP5T3

K010991 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 Special 510(k) pathway after a 30-day FDA review.

K010991 · Galil Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
30d
Days
Class 2
Risk

K010991 is an FDA 510(k) clearance for the SEEDNET, MODELS FP6T5, FP5T5, FP5T3. 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 May 3, 2001 after a review of 30 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.

FDA 510(k) Submission Details - K010991

510(k) Number K010991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2001
Decision Date May 03, 2001
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 239
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K010991.
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
K012497 · Galil Medical , Ltd. · Oct 2001
CRYOCARE SURGICAL SYSTEM
K003811 · Endocare, Inc. · Oct 2001
CRYOPLAN SYSTEM
K011073 · Cryomedical Sciences, Inc. · Aug 2001
WARTNER WART REMOVAL SYSTEM
K002714 · Wartner Medical Products · Nov 2000
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · Endocare, Inc. · Nov 2000
SEEDNET, MODEL EP6T5, EP5E5
K003065 · Galil Medical , Ltd. · Oct 2000