FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Accordion Piccolo Stone Management Device
K Number: K172299
·
Decision Sep 19, 2017
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
51
Applicant Total
1
Review Days
50
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
- Accordion Piccolo Stone Management Device
- K Number
- K172299
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ths International, Inc. D/B/A Accordion Medical
- Date Received
- July 31, 2017
- Decision Date
- September 19, 2017
- Product Code
- FFL
- 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 |
|---|---|---|---|
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFL), ordered by most recent decision date.
Peralta Stone Removal Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCORDION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REPROCESSED STONE RETRIEVAL BASKETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMS FOREIGN BODY EXTRATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology