510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K162588Substantially Equivalent

Möller Medical Biopsy Needles and Systems

Moller Medical GmbH, Fulda, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162588 is the FDA 510(k) clearance record for Möller Medical Biopsy Needles and Systems, a class II device, cleared for Moller Medical GmbH on under FDA product code KNW (Instrument, Biopsy). FDA records list 3 510(k) clearances for Moller Medical GmbH, from to . As of , FDA records show no recalls naming K162588.

Clearance record

Decision date
Received
(276 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Moller Medical GmbH Wasserkuppenstrabe 29-31, Fulda, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to October 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260