FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MediClear PreOp
K Number: K163556
·
Decision Sep 14, 2017
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
449
Applicant Total
6
Review Days
269
Basic Information
- Device Name
- MediClear PreOp
- K Number
- K163556
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COVALON TECHNOLOGIES, INC.
- Date Received
- December 19, 2016
- Decision Date
- September 14, 2017
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical | FDA class 2 | General, Plastic Surgery |
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| K Number | Device Name | ||
|---|---|---|---|
| K150550 | SilverCoat Silicone Foley Catheter | Nov 24, 2015 | Substantially Equivalent |
| K121819 | SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER | Aug 13, 2012 | Substantially Equivalent |
| K112549 | IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER | May 4, 2012 | Substantially Equivalent |
| K043296 | COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING | Jun 6, 2005 | Substantially Equivalent |
| K050177 | COLACTIVE COLLAGEN WOUND DRESSING | Apr 27, 2005 | Substantially Equivalent |