Cleared Special

K101139 - PROSTIVA RF THERAPY MODEL 8929 HAND PIECE

K101139 is an FDA 510(k) clearance for PROSTIVA RF THERAPY MODEL 8929 HAND PIECE, manufactured by Medtronic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Special 510(k) pathway after a 29-day FDA review.

K101139 · Medtronic, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
29d
Days
Class 2
Risk

K101139 is an FDA 510(k) clearance for the PROSTIVA RF THERAPY MODEL 8929 HAND PIECE. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 21, 2010 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology 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 - K101139

510(k) Number K101139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2010
Decision Date May 21, 2010
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 181
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K101139.
GYRUS ACMI BIOCOAG PROBE
K092571 · Gyrus Acmi, Inc. · Oct 2010
MERIT BIPOLAR COAGULATION PROBE
K102273 · Merit Medical Systems, Inc. · Sep 2010
TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
K093079 · Hobbs Medical, Inc. · Aug 2010
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
K092309 · Olympus Medical Systems Corporation · Oct 2009
HABIB ENDOHPB
K083292 · Emcision , Ltd. · Jun 2009
PRECISION ENDOSCOPIC INFRARED COAGULATOR
K083275 · Max Endoscopy, Inc. · Jun 2009
K101139 · PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
Download PDF FDA Summary Medtronic, Inc.