FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
BONDILOXS TOPICAL HEMOSTATIC DRESSING
K Number: K132333
·
Decision Jun 25, 2014
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
126
Applicant Total
21
Review Days
334
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Basic Information
- Device Name
- BONDILOXS TOPICAL HEMOSTATIC DRESSING
- K Number
- K132333
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtrade Products , Ltd.
- Date Received
- July 26, 2013
- Decision Date
- June 25, 2014
- Product Code
- QSY
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | FDA unclassified | Unknown |
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Other Clearances by Medtrade Products , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230589 | Celox Rapid X-Ray Gauze | Nov 17, 2023 | Substantially Equivalent |
| K161274 | Bondiloxs Topical Hemostatic Granules | Jan 18, 2017 | Substantially Equivalent |
| K120930 | CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING | Oct 26, 2012 | Substantially Equivalent |
| K113560 | CELOX GAUZE PRO | Aug 1, 2012 | Substantially Equivalent |
| K110386 | CELOX RAPID GAUZE | May 10, 2011 | Substantially Equivalent |
| K102965 | CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI | Dec 8, 2010 | Substantially Equivalent |
| K093519 | MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET | Jan 14, 2010 | Substantially Equivalent |
| K091795 | MEDTRADE PRODUCTS CELOX TRAUMA GAUZE | Nov 20, 2009 | Substantially Equivalent |
| K090780 | MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE | Nov 20, 2009 | Substantially Equivalent |
| K080097 | MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET | Jul 9, 2008 | Substantially Equivalent |