FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODULAR BIOPSY FORCEP
K Number: K946360
·
Decision Mar 6, 1995
Classifications
1
FEI Numbers
188
Registration Numbers
188
Same Product Code
38
Applicant Total
15
Review Days
66
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Basic Information
- Device Name
- MODULAR BIOPSY FORCEP
- K Number
- K946360
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cox Medical Ent., Inc.
- Date Received
- December 30, 1994
- Decision Date
- March 6, 1995
- Product Code
- FCL
- 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 |
|---|---|---|---|
| FCL | Forceps, Biopsy, Non-Electric | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
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OLYMPUS FB SERIES BIOPSY FORCEPS
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Other Clearances by Cox Medical Ent., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950689 | UCB | Mar 6, 1995 | Substantially Equivalent |
| K941464 | BASICS ENDOSCOPY SYSTEM | Aug 5, 1994 | Substantially Equivalent |
| K940911 | BASICS ENDOSCOPY SYSTEM | May 16, 1994 | Substantially Equivalent |
| K932790 | THERMAL OPTION | Jan 28, 1994 | Substantially Equivalent |
| K935250 | ACCU-PATH | Jan 21, 1994 | Substantially Equivalent |
| K924655 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) | Dec 15, 1992 | Substantially Equivalent |
| K923671 | COX DISPOSABLE POLYPECTOMY SNARES | Oct 13, 1992 | Substantially Equivalent |
| K923672 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH | Sep 23, 1992 | Substantially Equivalent |
| K923489 | COX DISPOSABLE RETRIEVAL DEVICES | Sep 23, 1992 | Substantially Equivalent |
| K914466 | COX DISPOSABLE CYTOLOGY BRUSHES | Oct 25, 1991 | Substantially Equivalent |