Atlas FDA

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider

FDA 510(k) clearance K153745 · decided 2016-05-02

Clearance details

K-number
K153745
Device name
Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
Applicant
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
Decision
Substantially Equivalent
Date received
2015-12-29
Decision date
2016-05-02
Days to decision
125 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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RecordFirmDate
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Reprocessed LigaSure Maryland Jaw Sealer/Divider (K180499)Stryker Sustainability Solutions2018-04-23
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Recalls involving this device

RecordFirmDate
Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Gene recall (Z-0468-2026)Medline Industries, LP2025-11-07
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator recall (Z-0469-2026)Medline Industries, LP2025-11-07
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compati recall (Z-3094-2024)MEDLINE INDUSTRIES, LP - Northfield2024-09-10
MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF recall (Z-0119-2024)MEDLINE INDUSTRIES, LP - Northfield2023-10-16