Modulith SLX-F2
FDA 510(k) clearance K201001 · decided 2021-03-30
Clearance details
- K-number
- K201001
- Device name
- Modulith SLX-F2
- Applicant
- Karl Storz Endoscopy America
- Decision
- Substantially Equivalent
- Date received
- 2020-04-16
- Decision date
- 2021-03-30
- Days to decision
- 348 days
- Clearance type
- Traditional
- Product code
- LNS
- Device class
- 2
- Regulation number
- 876.5990
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- El Segundo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.