Data / Medical devices / Israel / Elcam Medical A.C.A.L.
Elcam Medical A.C.A.L.: FDA-registered device maker in D.N. MEROM HAGALIL Northern, Israel, 4 510(k) clearances
Elcam Medical A.C.A.L. is registered with the FDA (registration 9612152) in D.N. MEROM HAGALIL Northern, Israel. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 25, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9612152
- FEI number
- 3002806901
- Address
- Kibbutz Bar-Am, D.N. MEROM HAGALIL Northern, Israel, 1386000
- Owner or operator
- Elcam Medical ACAL (8030082)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 28, 2002
- Registered through
- 2027
- Brand names listed
- A-TAP, Closed Stopcock and MRVLS, D600 Discofix ® High Flow Stopcock, DISPOSABLE TRANSPAC(R) ML INTEGRATE, Elcam HP HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold, Elcam Stopcocks and Manifolds, Elcam Stopcocks and Manifolds with Safe2 Rotator, Elcam Stopcocks and Manifolds with improved blister and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Blood-Pressure, Extravascular | DRS | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2023 | K231900 | A-TAP (previously called Arthrotap) | FMF | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| April 23, 2019 | K190489 | Elcam Stopcocks and Manifolds | FMG | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| April 13, 2006 | K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK | FMG | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| October 18, 2002 | K022895 | ELCAM STOPCOCKS AND MANIFOLDS | FMG | Substantially Equivalent | Medical Device Consultants, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stopcock, I.V. Set
- All makers of Transducer, Blood-Pressure, Extravascular
- All makers of Syringe, Piston
- All makers of Set, Administration, Intravascular
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Catheter, Intravascular, Diagnostic
Updated July 25, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.