FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOMED URETERAL STONE DISLODGERS
K Number: K854652
·
Decision Feb 10, 1986
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
51
Applicant Total
24
Review Days
83
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
- ANGIOMED URETERAL STONE DISLODGERS
- K Number
- K854652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Angiomed U.S., Inc.
- Date Received
- November 19, 1985
- Decision Date
- February 10, 1986
- 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 Piccolo Stone Management Device
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
Other Clearances by Angiomed U.S., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874771 | ANGIOMED INTRODUCING SETS | Jan 12, 1988 | Substantially Equivalent |
| K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | Dec 2, 1987 | Substantially Equivalent |
| K864225 | ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT | Jan 30, 1987 | Substantially Equivalent |
| K863386 | VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS | Oct 24, 1986 | Substantially Equivalent |
| K862805 | ANGIOMED VAC-U-CUT BIOPSY NEEDLE | Sep 29, 1986 | Substantially Equivalent |
| K863446 | ANGIOMED HIGH PRESSURE CONNECTORS | Sep 23, 1986 | Substantially Equivalent |
| K854910 | ANGIOFLOW | Jul 17, 1986 | Substantially Equivalent |
| K854912 | ANGIOMED GUIED WIRES | Apr 16, 1986 | Substantially Equivalent |
| K854908 | UROFLEX | Mar 14, 1986 | Substantially Equivalent |
| K855142 | ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY | Mar 11, 1986 | Substantially Equivalent |