FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Enteral Transition Adaptor
K Number: K220165
·
Decision Oct 21, 2022
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
8
Applicant Total
2
Review Days
274
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Basic Information
- Device Name
- Enteral Transition Adaptor
- K Number
- K220165
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GBUK Group, Ltd.
- Date Received
- January 20, 2022
- Decision Date
- October 21, 2022
- Product Code
- PIO
- 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 |
|---|---|---|---|
| PIO | Enteral Specific Transition Connectors | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by GBUK Group, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K203633 | Enteral Extension Sets | Aug 19, 2021 | Substantially Equivalent |