FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ViSiGi 3D Gastric Sizing Tube
K Number: K234145
·
Decision Jan 26, 2024
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
38
Review Days
28
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Basic Information
- Device Name
- ViSiGi 3D Gastric Sizing Tube
- K Number
- K234145
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boehringer Laboratories
- Date Received
- December 29, 2023
- Decision Date
- January 26, 2024
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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| K955010 | AUTOVAC BP SYSTE, 2000 SERIES | Jun 20, 1996 | Substantially Equivalent |
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| K932093 | AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S | Jul 6, 1994 | Substantially Equivalent |
| K933232 | BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED | Mar 28, 1994 | Substantially Equivalent |
| K930615 | AUTOVAC CLOSED WOUND SUCTION SYSTEM | Feb 22, 1994 | Substantially Equivalent |