Cleared Special

K033177 - POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033177 · Gunter Bissinger Medizintechnik GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
162d
Days
Class 2
Risk

K033177 is an FDA 510(k) clearance for the POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Gunter Bissinger Medizintechnik GmbH (Amsterdam, Nh, NL). The FDA issued a Cleared decision on March 11, 2004 after a review of 162 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gunter Bissinger Medizintechnik GmbH devices

Submission Details

510(k) Number K033177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2003
Decision Date March 11, 2004
Days to Decision 162 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 160d · This submission: 162d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K033177.
SIRIUS Endoscope System (PR-SI-1230)
K250939 · Precision Robotics (Hong Kong) Limited · Aug 2025
i-Cut
K243821 · A.M.I. Agency For Medical Innovations GmbH · Apr 2025
SIRIUS Endoscope System
K221642 · Precision Robotics (Hong Kong) Limited · Dec 2022
Video Endoscopy System, 3D Video Endoscopy System
K210116 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Oct 2021
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
K201832 · Olympus Medical Systems Corp. · Sep 2021
SurroundScope System
K210104 · 270surgical , Ltd. · Jul 2021