Precision GI
FDA 510(k) clearance K231422 · decided 2023-08-28
Clearance details
- K-number
- K231422
- Device name
- Precision GI
- Applicant
- Limaca Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-17
- Decision date
- 2023-08-28
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- En Ha'Emeq, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.