CompactCath Intermittent Urinary Catheter
FDA 510(k) clearance K160858 · decided 2016-04-26
Clearance details
- K-number
- K160858
- Device name
- CompactCath Intermittent Urinary Catheter
- Applicant
- Compactcath, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-29
- Decision date
- 2016-04-26
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- EZD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.