Custodiol HTK Solution
FDA 510(k) clearance K192408 · decided 2020-04-24
Clearance details
- K-number
- K192408
- Device name
- Custodiol HTK Solution
- Applicant
- Dr. Franz Kohler Chemie GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-09-04
- Decision date
- 2020-04-24
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- KDL
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bensheim, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Custodiol HTK Solution, 500ml bottle. 10 per carton. recall (Z-3300-2024) | Dr Franz Koehler Chemie Gmbh | 2024-09-26 |