Cleared Special

K033177 - POWERGRIP BIPOLAR COAGULATION FORCEPS

K033177 is an FDA 510(k) clearance for POWERGRIP BIPOLAR COAGULATION FORCEPS, manufactured by Gunter Bissinger Medizintechnik GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Special 510(k) pathway after a 162-day FDA review.

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

FDA 510(k) Submission Details - K033177

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.

HET Device Classification - Class 2, Special Controls

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 178
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K033177.
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APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
K040295 · Applied Medical Resources Corp. · Mar 2004
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K021237 · CooperSurgical, Inc. · Apr 2003
BALLOON CANNULA, SHORT, MODEL R65-985
K010510 · A & A Medical, Inc. · May 2001
MINI FIBER ENDOSCOPES
K003417 · Richard Wolf Medical Instruments Corp. · Apr 2001