Atlas FDA

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider

FDA 510(k) clearance K182588 · decided 2018-10-31

Clearance details

K-number
K182588
Device name
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
Applicant
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
Decision
Substantially Equivalent
Date received
2018-09-20
Decision date
2018-10-31
Days to decision
41 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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Recalls involving this device

RecordFirmDate
Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Gen recall (Z-0475-2026)Medline Industries, LP2025-11-07
Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm F recall (Z-0476-2026)Medline Industries, LP2025-11-07
Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Gene recall (Z-0477-2026)Medline Industries, LP2025-11-07
Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Co recall (Z-3093-2024)MEDLINE INDUSTRIES, LP - Northfield2024-09-10
MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Gen recall (Z-0118-2024)MEDLINE INDUSTRIES, LP - Northfield2023-10-16