FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METAL URETERAL BASKET STONE DISLODGER
K Number: K934675
·
Decision Jan 7, 1994
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
51
Applicant Total
23
Review Days
101
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Basic Information
- Device Name
- METAL URETERAL BASKET STONE DISLODGER
- K Number
- K934675
- 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 28, 1993
- Decision Date
- January 7, 1994
- 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 |
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ACCORDION
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REPROCESSED STONE RETRIEVAL BASKETS
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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 |
| 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 |
| K924027 | DISLODGER, STONE, BASKET, URETERAL, METAL | Oct 20, 1992 | Substantially Equivalent |