510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003123Substantially Equivalent

Renax A.v. Fistula Needle Sets

Sunder Biomedical Tech. Co., Ltd., Taichung City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003123 is the FDA 510(k) clearance record for RENAX A.V. FISTULA NEEDLE SETS, a class II device, cleared for Sunder Biomedical Tech. Co., Ltd. on under FDA product code FIE (Needle, Fistula). FDA records list 3 510(k) clearances for Sunder Biomedical Tech. Co., Ltd., from to . As of , FDA records show no recalls naming K003123.

Clearance record

Decision date
Received
(211 days to decision)
Product code
FIE Needle, Fistula
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sunder Biomedical Tech. Co., Ltd. 10f-1, 1-67, Wu-Chuan Rd., Taichung City, TW
510(k) summary
Summary
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