FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BASICS ENDOSCOPY SYSTEM
K Number: K941464
·
Decision Aug 5, 1994
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
73
Applicant Total
15
Review Days
130
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Basic Information
- Device Name
- BASICS ENDOSCOPY SYSTEM
- K Number
- K941464
- 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
- March 28, 1994
- Decision Date
- August 5, 1994
- Product Code
- OCZ
- 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 |
|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 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 |
| 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 |