ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
FDA 510(k) clearance K131072 · decided 2013-07-09
Clearance details
- K-number
- K131072
- Device name
- ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 2013-04-17
- Decision date
- 2013-07-09
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- OCY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.