FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY FORCEPS
K Number: K895098
·
Decision Oct 30, 1989
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
22
Applicant Total
23
Review Days
76
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Basic Information
- Device Name
- BIOPSY FORCEPS
- K Number
- K895098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4075
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Annex Medical, Inc.
- Date Received
- August 15, 1989
- Decision Date
- October 30, 1989
- Product Code
- DWZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DWZ | Device, Biopsy, Endomyocardial | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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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 |
| 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 |