Cleared Traditional

K990147 - BIPOLAR FORCEPS

K990147 is the FDA 510(k) clearance for BIPOLAR FORCEPS by Richard Wolf Medical Instruments Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HIN) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K990147 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
87d
Days
Class 2
Risk

K990147 is an FDA 510(k) clearance for the BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.... Classified as Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (product code HIN), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on April 16, 1999 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K990147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1999
Decision Date April 16, 1999
Days to Decision 87 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
73d faster than avg
Panel avg: 160d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (HIN) and FDA review panel - the closest regulatory comparables to K990147.
PKS BILL
K122605 · Gyrus Acmi, Inc. · Dec 2012
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
K111751 · Ethicon, Inc. · Dec 2011
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
K111059 · Gyrus Acmi, Inc. · Sep 2011
COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES
K943776 · Richard Wolf Medical Instruments Corp. · Nov 1994
MODEL 26021C BIPOLAR COAGULATOR
K871745 · KARL STORZ Endoscopy-America, Inc. · Jul 1987