EnteraLoc Flow
FDA 510(k) clearance K210971 · decided 2021-08-18
Clearance details
- K-number
- K210971
- Device name
- EnteraLoc Flow
- Applicant
- Vonco Products
- Decision
- Substantially Equivalent
- Date received
- 2021-03-31
- Decision date
- 2021-08-18
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- PIF
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Trevor, WI, 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.