510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112734Substantially Equivalent

Aplan A.v. Fistula Needle Set

Aplan Well Enterprise Co., Ltd., Hsin Chu City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112734 is the FDA 510(k) clearance record for APLAN A.V. FISTULA NEEDLE SET, a class II device, cleared for Aplan Well Enterprise Co., Ltd. on under FDA product code FIE (Needle, Fistula). FDA records list one 510(k) clearance for Aplan Well Enterprise Co., Ltd. As of , FDA records show no recalls naming K112734.

Clearance record

Decision date
Received
(217 days to decision)
Product code
FIE Needle, Fistula
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Aplan Well Enterprise Co., Ltd. # 58, Fu Chiun St., Hsin Chu City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FIE

Trailing 12 months
1 clearance under product code FIE in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FIE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260