FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VELCRO TOURNIQUET
K Number: K853537
·
Decision Sep 12, 1985
Classifications
1
FEI Numbers
335
Registration Numbers
335
Same Product Code
19
Applicant Total
31
Review Days
20
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Basic Information
- Device Name
- VELCRO TOURNIQUET
- K Number
- K853537
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5900
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cp Medical
- Date Received
- August 23, 1985
- Decision Date
- September 12, 1985
- Product Code
- GAX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAX), ordered by most recent decision date.
UNIQUET
FDA 510(k)
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TOURNIQUET
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STERILE ESMARCH BANDAGE
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DEGANIA SILICONE TOURNIQUET
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FDA Class 1
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UNIVERSAL TOURNIQUET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KINDERWRAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Cp Medical
| K Number | Device Name | ||
|---|---|---|---|
| K094028 | CP-FIBER (ORTHOFIBER) | Mar 18, 2010 | Substantially Equivalent |
| K072229 | MONOSWIFT | Oct 5, 2007 | Substantially Equivalent |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | Jul 18, 2007 | Substantially Equivalent |
| K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 | Nov 2, 2006 | Substantially Equivalent |
| K041894 | ORTHOFIBER | Sep 17, 2004 | Substantially Equivalent |
| K034062 | CP SLEEVE AND RIVER SLEEVE | Jan 30, 2004 | Substantially Equivalent |
| K024372 | CP MEDICAL BONE WAX | Jun 19, 2003 | Substantially Equivalent |
| K030786 | MONO-SWIFT | May 6, 2003 | Substantially Equivalent |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Mar 28, 2003 | Substantially Equivalent |
| K023710 | VISORB SWIFT | Jan 17, 2003 | Substantially Equivalent |