Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer— 510(k) K250314
Substantially EquivalentSurgical Instrument Service and Savings, Inc.
FDA 510(k) clearance K250314 for Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer, Substantially Equivalent on 2025-12-19. Applicant: Surgical Instrument Service and Savings, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Product code
- Code PNE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.