Cleared Special

K052861 - MODIFICATION TO:SANARUS VISICA TREATMEN...

K052861 is an FDA 510(k) clearance for MODIFICATION TO:SANARUS VISICA TREATMEN..., 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 35-day FDA review.

K052861 · Sanarus Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
35d
Days
Class 2
Risk

K052861 is an FDA 510(k) clearance for the MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000. 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 November 15, 2005 after a review of 35 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 - K052861

510(k) Number K052861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2005
Decision Date November 15, 2005
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 K052861.
ATRICURE CRYO MODULE
K111042 · AtriCure, Inc. · May 2011
ATRICURE CRYO1 CRYO-ABLATION PROBE
K082074 · AtriCure, Inc. · Mar 2009
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
K060859 · OraSure Technologies, Inc. · Jul 2006
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
K051509 · Erbe USA, Inc. · Jul 2005
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
K023487 · OraSure Technologies, Inc. · Mar 2003
HISTOFREEZER DEVICE
K990877 · OraSure Technologies, Inc. · Jun 1999