SPEEDICATH COMPACT
FDA 510(k) clearance K072808 · decided 2007-11-09
Clearance details
- K-number
- K072808
- Device name
- SPEEDICATH COMPACT
- Applicant
- Coloplast Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-01
- Decision date
- 2007-11-09
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- GBM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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| Titan Inflatable Penile Prosthesis (IPP) (P000006/S066) | Coloplast Corp. | 2023-02-15 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S065) | Coloplast Corp. | 2023-01-12 |