Atlas FDA

ELCAM STOPCOCKS AND MANIFOLDS

FDA 510(k) clearance K022895 · decided 2002-10-18

Clearance details

K-number
K022895
Device name
ELCAM STOPCOCKS AND MANIFOLDS
Applicant
Medical Device Consultants, Inc.
Decision
Substantially Equivalent
Date received
2002-09-03
Decision date
2002-10-18
Days to decision
45 days
Clearance type
Traditional
Product code
FMG
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
North Attleboro, MA, 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
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0641-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0642-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0643-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0644-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0717-2026)B Braun Medical Inc2025-11-26
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way recall (Z-3144-2024)B. Braun Medical, Inc.2024-09-13
Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension recall (Z-0646-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifol recall (Z-0653-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating recall (Z-0654-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock Extension Set recall (Z-0655-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating recall (Z-0656-06)Baxter Healthcare Corp.2006-03-24
Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension recall (Z-0943-05)Baxter Healthcare Corp.2005-06-30