FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMART DILATOR
K Number: K082995
·
Decision Feb 6, 2009
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
39
Applicant Total
1
Review Days
121
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
- SMART DILATOR
- K Number
- K082995
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Safestitch Medical
- Date Received
- October 8, 2008
- Decision Date
- February 6, 2009
- Product Code
- KNQ
- 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 |
|---|---|---|---|
| KNQ | Dilator, Esophageal | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNQ), ordered by most recent decision date.
CRE FIXED WIRE BALLON DILATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ETHICON ENDO-SURGERYOPTICAL DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology