SpeediCath Flex Set
FDA 510(k) clearance K222059 · decided 2022-09-21
Clearance details
- K-number
- K222059
- Device name
- SpeediCath Flex Set
- Applicant
- Coloplast
- Decision
- Substantially Equivalent
- Date received
- 2022-07-13
- Decision date
- 2022-09-21
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- EZD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.