SUPRAPUBIC CATHETER AND INTRODUCER SET
FDA 510(k) clearance K132890 · decided 2014-01-17
Clearance details
- K-number
- K132890
- Device name
- SUPRAPUBIC CATHETER AND INTRODUCER SET
- Applicant
- Mediplus , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-16
- Decision date
- 2014-01-17
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- KOB
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- High Wycombe, Bucks, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.