Cleared Traditional

K111751 - VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS

K111751 is an FDA 510(k) clearance for VERSAPOINT II BIPOLAR ELECTROSURGERY GE..., manufactured by Ethicon, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIN cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K111751 · Ethicon, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
163d
Days
Class 2
Risk

K111751 is an FDA 510(k) clearance for the VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOO.... Classified as Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (product code HIN), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 2, 2011 after a review of 163 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4150 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

FDA 510(k) Submission Details - K111751

510(k) Number K111751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2011
Decision Date December 02, 2011
Days to Decision 163 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 160d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIN Device Classification - Class 2, Special Controls

Product Code HIN Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4150
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIN Coagulator-cutter, Endoscopic, Bipolar (and Accessories)

All 14
Devices cleared under the same product code (HIN) and FDA review panel - the closest regulatory comparables to K111751.
KSEA BIPOLAR ELECTRODE
K122983 · KARL STORZ Endoscopy-America, Inc. · Jun 2013
PKS BILL
K122605 · Gyrus Acmi, Inc. · Dec 2012
TUBALGATOR
K113080 · Mectra Labs, Inc. · Jun 2012
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
K111059 · Gyrus Acmi, Inc. · Sep 2011
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771
K990147 · Richard Wolf Medical Instruments Corp. · Apr 1999
BICOAG COAGULATING FORCEPS
K971565 · Everest Medical Corp. · Mar 1998