510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K033177Substantially Equivalent

Powergrip Bipolar Coagulation Forceps, Model 824Xxxxx

Gunter Bissinger Medizintechnik GmbH, Amsterdam, Nh, NL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033177 is the FDA 510(k) clearance record for POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX, a class II device, cleared for Gunter Bissinger Medizintechnik GmbH on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 2 510(k) clearances for Gunter Bissinger Medizintechnik GmbH, from to . As of , FDA records show no recalls naming K033177.

Clearance record

Decision date
Received
(162 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gunter Bissinger Medizintechnik GmbH Amstel 320-I, Amsterdam, Nh, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HET

Trailing 12 months

FDA records hold no clearances under product code HET in the trailing twelve months.

FDA records show no clearances under product code HET in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260