FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POGO SCREW INSTRUMENTATION TRAY
K Number: K091806
·
Decision Feb 22, 2010
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
279
Applicant Total
4
Review Days
249
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
- POGO SCREW INSTRUMENTATION TRAY
- K Number
- K091806
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fxdevices
- Date Received
- June 18, 2009
- Decision Date
- February 22, 2010
- Product Code
- KCT
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCT), ordered by most recent decision date.
SteriBest® Sterilization Tray System
FDA 510(k)
FDA Class 2
·General Hospital
SteriTite Container System with MediTray Products
FDA 510(k)
FDA Class 2
·General Hospital
Straumann® ProClean Cassette (041.800 ; 041.801)
FDA 510(k)
FDA Class 2
·General Hospital
PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
FDA 510(k)
FDA Class 2
·General Hospital
Stainless Steel Surgical Kits
FDA 510(k)
FDA Class 2
·General Hospital
Sterilization Trays
FDA 510(k)
FDA Class 2
·General Hospital