Atlas FDA

STOPCOCK & LUER LOCK PLUG

FDA 510(k) clearance K954970 · decided 1996-04-22

Clearance details

K-number
K954970
Device name
STOPCOCK & LUER LOCK PLUG
Applicant
Medex, Inc.
Decision
Substantially Equivalent
Date received
1995-10-30
Decision date
1996-04-22
Days to decision
175 days
Clearance type
Traditional
Product code
FMG
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Dublin, OH, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Qitexio® 4-Way Stopcock (QIT014) (K242255)Medex2025-04-29
Three Way Stop Cock (K223499)M/S Romsons International2023-07-21
lntravascular Administration Sets with Stopcock and Manifold (K223175)Baxter Healthcare Corporation2023-03-10
SafePort(TM) Manifold (or Stopcock) (K211204)Elcam Medical Acal2022-09-15
Clicky Cross (K210516)Yomura Technologies, Inc.2022-05-16
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile (K190539)Monumedical, LLC2019-10-22
Elcam Stopcocks and Manifolds (K190489)Elcam Medical Acal2019-04-23
Dynarex Three-Way Stopcock (K172266)Dynarex Corporation2018-03-14
ELCAM STOPCOCKS AND MANIFOLDS (K141254)Elcam Medical Acal2014-07-30
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD (K123084)Elcam Medical Acal2013-05-23
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245)Baxter Healthcare Corp2013-03-01
DUAL SYRINGE HOLDER (K082110)Surgin Surgical Instrumentation, Inc.2009-06-17

Recalls involving this device

RecordFirmDate
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR recall (Z-0745-2024)Smiths Medical Asd Inc2024-01-17