FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
SURGICAL DRAPE
K Number: K140195
·
Decision Sep 10, 2014
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
1
Review Days
226
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SURGICAL DRAPE
- K Number
- K140195
- 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
- Griffith-Lucas, LLC
- Date Received
- January 27, 2014
- Decision Date
- September 10, 2014
- 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, Antimicrobial | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KKX), ordered by most recent decision date.
BeneHold Surgical Incise Drape with CHG antimicrobial II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BeneHold Surgical Incise Drape with CHG antimicrobial
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ControlRad Sterile Cover
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MediClear PreOp
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Plus Surgical Drapes (EO Sterilized), PMDB-XXX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery