FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)
K Number: K924655
·
Decision Dec 15, 1992
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
56
Applicant Total
15
Review Days
91
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Basic Information
- Device Name
- COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)
- K Number
- K924655
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cox Medical Ent., Inc.
- Date Received
- September 15, 1992
- Decision Date
- December 15, 1992
- Product Code
- FEB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Cox Medical Ent., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946360 | MODULAR BIOPSY FORCEP | Mar 6, 1995 | Substantially Equivalent |
| 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 |
| 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 |