Atlas FDA

Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider

FDA 510(k) clearance K160333 · decided 2016-07-20

Clearance details

K-number
K160333
Device name
Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
Applicant
Surgical Instrument Service and Savings, Inc.
Decision
Substantially Equivalent
Date received
2016-02-08
Decision date
2016-07-20
Days to decision
163 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

RecordFirmDate
Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x recall (Z-0471-2026)Medline Industries, LP2025-11-07
Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generato recall (Z-0472-2026)Medline Industries, LP2025-11-07
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generat recall (Z-0473-2026)Medline Industries, LP2025-11-07
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generat recall (Z-0474-2026)Medline Industries, LP2025-11-07
Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Comp recall (Z-3092-2024)MEDLINE INDUSTRIES, LP - Northfield2024-09-10
MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generat recall (Z-0117-2024)MEDLINE INDUSTRIES, LP - Northfield2023-10-16