510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212822Substantially Equivalent

Disposable Coaxial Biopsy Needle

Suzhou Leapmed Healthcare Corporation, Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212822 is the FDA 510(k) clearance record for Disposable Coaxial Biopsy Needle, a class II device, cleared for Suzhou Leapmed Healthcare Corporation on under FDA product code FCG (Biopsy Needle). FDA records list 4 510(k) clearances for Suzhou Leapmed Healthcare Corporation, from to . As of , FDA records show no recalls naming K212822.

Clearance record

Decision date
Received
(306 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Suzhou Leapmed Healthcare Corporation Wuzhong Science Park, #2 & #3 Bldg., Suzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCG

Trailing 12 months

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

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