510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K990470Substantially Equivalent

Jms a. V. Fistula Needle Set

JMS Co., Ltd., Hiroshima, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990470 is the FDA 510(k) clearance record for JMS A. V. FISTULA NEEDLE SET, a class II device, cleared for Jms Co., Ltd. on under FDA product code FIE (Needle, Fistula). FDA records list 21 510(k) clearances for Jms Co., Ltd., from to . As of , FDA records show no recalls naming K990470.

Clearance record

Decision date
Received
(195 days to decision)
Product code
FIE Needle, Fistula
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Jms Co., Ltd. 12-17, Kako-Machi, Naka-Ku, Hiroshima, JP
510(k) summary
Statement
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