FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROTOSNARE
K Number: K992477
·
Decision Aug 24, 1999
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
62
Applicant Total
2
Review Days
29
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
- ROTOSNARE
- K Number
- K992477
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inscope, LLC
- Date Received
- July 26, 1999
- Decision Date
- August 24, 1999
- Product Code
- FDI
- 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 |
|---|---|---|---|
| FDI | Snare, Flexible | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FDI), ordered by most recent decision date.
Advanced Tissue Resection Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polypectomy Snare
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORE-SNARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Polyp Snare
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Polypectomy Snare
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Inscope, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K013889 | ENDOSCOPIC MULTI-FIRE CLIP APPLIER | Feb 7, 2002 | Substantially Equivalent |