FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROTEK EQUIPMENT DRAPES
K Number: K050322
·
Decision May 17, 2005
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
24
Review Days
97
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
- MICROTEK EQUIPMENT DRAPES
- K Number
- K050322
- 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
- Microtek Medical, Inc.
- Date Received
- February 9, 2005
- Decision Date
- May 17, 2005
- 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
Other Clearances by Microtek Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110358 | VENODYNE V810 | May 5, 2011 | Substantially Equivalent |
| K102971 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK | Feb 23, 2011 | Substantially Equivalent |
| K062899 | MICROTEK MEDICAL SURGICAL GOWN/TOGA | Jan 25, 2007 | Substantially Equivalent |
| K060200 | MICROTEK MEDICAL WARMING DRAPE | May 31, 2006 | Substantially Equivalent |
| K022903 | CHILLBUSTER | Nov 27, 2002 | Substantially Equivalent |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | May 16, 2002 | Substantially Equivalent |
| K011318 | VENODYNE DVT ADVANTAGE PLUS | Oct 25, 2001 | Substantially Equivalent |
| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | Jan 9, 2001 | Substantially Equivalent |
| K950906 | LESINSKI SURGICAL EAR DRESSING | Jun 22, 1995 | Substantially Equivalent |
| K925610 | FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN | Nov 18, 1994 | Substantially Equivalent |