SKOUT® system— 510(k) K230658
Substantially EquivalentIterative Scopes, Inc.
FDA 510(k) clearance K230658 for SKOUT® system, Substantially Equivalent on 2023-04-07. Applicant: Iterative Scopes, Inc.. Device class: 2.
Clearance details
- Applicant
- Iterative Scopes, Inc.
- Product code
- Code QNP
- Device class
- Class 2
- Regulation
- 21 CFR 876.1520
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cambridge, MA, US
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