FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRASPING FORCEPS OR RETRIEVAL FORCEPS
K Number: K925267
·
Decision Feb 10, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
23
Review Days
114
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Basic Information
- Device Name
- GRASPING FORCEPS OR RETRIEVAL FORCEPS
- K Number
- K925267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Annex Medical, Inc.
- Date Received
- October 19, 1992
- Decision Date
- February 10, 1993
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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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 |
| K934675 | METAL URETERAL BASKET STONE DISLODGER | Jan 7, 1994 | Substantially Equivalent |
| K934598 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Jan 7, 1994 | 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 |