FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY FORCEPS
K Number: K921401
·
Decision Oct 21, 1992
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
22
Applicant Total
23
Review Days
211
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
- BIOPSY FORCEPS
- K Number
- K921401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4075
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Annex Medical, Inc.
- Date Received
- March 24, 1992
- Decision Date
- October 21, 1992
- 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
Other 510(k) clearances with the same product code (DWZ), ordered by most recent decision date.
Biopsy Forceps
FDA 510(k)
FDA Class 2
·Cardiovascular
Biopsy Forceps
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVATOME, MODEL: SU101-50
FDA 510(k)
FDA Class 2
·Cardiovascular
SPARROWHAWK DISPOSABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO T-REX BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRA-CBX
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K924027 | DISLODGER, STONE, BASKET, URETERAL, METAL | Oct 20, 1992 | Substantially Equivalent |