FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
K Number: K960173
·
Decision Jun 27, 1996
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
7
Applicant Total
5
Review Days
163
Basic Information
- Device Name
- INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
- K Number
- K960173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GABRIEL MEDICAL, INC.
- Date Received
- January 16, 1996
- Decision Date
- June 27, 1996
- Product Code
- FAT
- 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 |
|---|---|---|---|
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by GABRIEL MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II | Feb 7, 1995 | Substantially Equivalent |
| K945297 | INFRA VISION IMAGING SYSTEM | Dec 20, 1994 | Substantially Equivalent |
| K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM | May 2, 1994 | Substantially Equivalent |
| K901385 | GABRIEL MEDICAL CLS THERMAL RECORDER | May 9, 1990 | Substantially Equivalent |