FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE
K Number: K914112
·
Decision Feb 28, 1992
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
18
Applicant Total
23
Review Days
168
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Basic Information
- Device Name
- METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE
- K Number
- K914112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Annex Medical, Inc.
- Date Received
- September 13, 1991
- Decision Date
- February 28, 1992
- Product Code
- FGO
- 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 |
|---|---|---|---|
| FGO | Dislodger, Stone, Flexible | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGO), ordered by most recent decision date.
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STONE DISLODGER, BASKET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RETRIEVAL SNARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STONE DISLODGER, BASKET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GRASPING FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Annex Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954377 | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | Oct 26, 1995 | Substantially Equivalent |
| K952863 | FORCEPS, BIOPSY, NON-ELECTRIC | Jul 19, 1995 | Substantially Equivalent |
| K951532 | METAL URETERAL BASKET STONE DISLODGER | Jul 19, 1995 | Substantially Equivalent |
| K951761 | METEL URETERAL BASKET STONE DISLODGER | May 11, 1995 | Substantially Equivalent |
| K934636 | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | Feb 25, 1994 | Substantially Equivalent |
| K934675 | METAL URETERAL BASKET STONE DISLODGER | Jan 7, 1994 | Substantially Equivalent |
| K934598 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Jan 7, 1994 | Substantially Equivalent |
| K925267 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Feb 10, 1993 | Substantially Equivalent |
| K925559 | BILIARY STONE DISLODGER | Dec 17, 1992 | Substantially Equivalent |
| K921401 | BIOPSY FORCEPS | Oct 21, 1992 | Substantially Equivalent |