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
K134019Substantially Equivalent

Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector, Medisystems Onesite Dual Lumen Butto

NxStage Medical Inc, Lawrence MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K134019 is the FDA 510(k) clearance record for MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO, a class II device, cleared for Nxstage Medical, Inc. on under FDA product code FIE (Needle, Fistula). FDA records list 51 510(k) clearances for Nxstage Medical, Inc., from to . As of , FDA records show no recalls naming K134019.

Clearance record

Decision date
Received
(255 days to decision)
Product code
FIE Needle, Fistula
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nxstage Medical, Inc. 350 Merrimack St., Lawrence MA
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