FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BACKSTOP AND BACKSTOP INJECTOR
K Number: K090430
·
Decision Jun 2, 2009
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
4
Review Days
103
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
- BACKSTOP AND BACKSTOP INJECTOR
- K Number
- K090430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pluromed, Inc.
- Date Received
- February 19, 2009
- Decision Date
- June 2, 2009
- Product Code
- ONJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| ONJ | Dissolvable Gel For Preventing Ureteral Stone Migration | FDA class 2 | Gastroenterology, Urology |