Cleared Special

K061510 - SANARUS VISICA TREATMENT SYSTEM

K061510 is an FDA 510(k) clearance for SANARUS VISICA TREATMENT SYSTEM, manufactured by Sanarus Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Special 510(k) pathway after a 47-day FDA review.

K061510 · Sanarus Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
47d
Days
Class 2
Risk

K061510 is an FDA 510(k) clearance for the SANARUS VISICA TREATMENT SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Sanarus Medical, Inc. (Pleasanton, US). The FDA issued a Cleared decision on July 18, 2006 after a review of 47 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 Sanarus Medical, Inc. devices

FDA 510(k) Submission Details - K061510

510(k) Number K061510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2006
Decision Date July 18, 2006
Days to Decision 47 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 115d · This submission: 47d
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 93
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K061510.
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ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
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K023487 · OraSure Technologies, Inc. · Mar 2003
HISTOFREEZER DEVICE
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