Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
FDA 510(k) clearance K232511 · decided 2024-04-29
Clearance details
- K-number
- K232511
- Device name
- Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-18
- Decision date
- 2024-04-29
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- NUJ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1. recall (Z-0467-2026) | Medline Industries, LP | 2025-11-07 |