FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
hygh-tec Drainage II
K Number: K242336
·
Decision Jan 17, 2025
Classifications
1
FEI Numbers
242
Registration Numbers
243
Same Product Code
648
Applicant Total
1
Review Days
163
Basic Information
- Device Name
- hygh-tec Drainage II
- K Number
- K242336
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AMB Medtec
- Date Received
- August 7, 2024
- Decision Date
- January 17, 2025
- 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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