510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K881412Substantially Equivalent

Myocard Biopsy Forcep

Fehling Medizintechnik GmbH, West Germany, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881412 is the FDA 510(k) clearance record for MYOCARD BIOPSY FORCEP, a class II device, cleared for Fehling Medizintechnik GmbH on under FDA product code DWZ (Device, Biopsy, Endomyocardial). FDA records list one 510(k) clearance for Fehling Medizintechnik GmbH. As of , FDA records show no recalls naming K881412.

Clearance record

Decision date
Received
(157 days to decision)
Product code
DWZ Device, Biopsy, Endomyocardial
Regulation
21 CFR 870.4075
Device class
Class II
Review panel
Cardiovascular
Applicant
Fehling Medizintechnik GmbH Postfach 1109, Frankenstrabe, West Germany, DE
Third party review
No

Clearances, product code DWZ

Trailing 12 months

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

FDA records show no clearances under product code DWZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWZ, 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