510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K143546Substantially Equivalent

Imbibe Aspirating XIA Taps

Stryker Corp., Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143546 is the FDA 510(k) clearance record for Imbibe Aspirating XIA Taps, a class II device, cleared for Stryker Corporation on under FDA product code KNW (Instrument, Biopsy). FDA records list 568 510(k) clearances for Stryker Corporation, from to . As of , FDA records show no recalls naming K143546.

Clearance record

Decision date
Received
(94 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Stryker Corporation 2 Pearl Ct., Allendale NJ
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