FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Elcam Stopcocks and Manifolds
K Number: K190489
·
Decision Apr 23, 2019
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
16
Review Days
54
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Basic Information
- Device Name
- Elcam Stopcocks and Manifolds
- K Number
- K190489
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elcam Medical Acal
- Date Received
- February 28, 2019
- Decision Date
- April 23, 2019
- Product Code
- FMG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | FDA class 2 | General Hospital |
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Other Clearances by Elcam Medical Acal
| K Number | Device Name | ||
|---|---|---|---|
| K231900 | A-TAP (previously called Arthrotap) | Jul 25, 2023 | Substantially Equivalent |
| K211204 | SafePort(TM) Manifold (or Stopcock) | Sep 15, 2022 | Substantially Equivalent |
| K141254 | ELCAM STOPCOCKS AND MANIFOLDS | Jul 30, 2014 | Substantially Equivalent |
| K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD | May 23, 2013 | Substantially Equivalent |
| K120253 | ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) | Jul 16, 2012 | Substantially Equivalent |
| K120624 | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) | Jun 8, 2012 | Substantially Equivalent |
| K111467 | FLEXI-Q DV AND DVR AUTO-INJECTORS | Feb 9, 2012 | Substantially Equivalent |
| K111016 | SAFEPORT MANIFOLD (TM) (OR STOPCOCK) | Jun 9, 2011 | Substantially Equivalent |
| K100425 | HASKAL TORQUE DEVICE | Jun 17, 2010 | Substantially Equivalent |
| K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Oct 2, 2008 | Substantially Equivalent |