FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator
FDA 510(k) clearance K150705 · decided 2015-04-13
Clearance details
- K-number
- K150705
- Device name
- FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator
- Applicant
- Minimally Invasive Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-18
- Decision date
- 2015-04-13
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Columbus, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.