510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153745Substantially Equivalent

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider

Surgical Instrument Service and Savings Inc.(Dba Medline Ren, Redmond OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153745 is the FDA 510(k) clearance record for Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider, a class II device, cleared for Surgical Instrument Service and Savings Inc.(Dba Medline Ren on under FDA product code NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed). FDA's definition for product code NUJ reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". FDA records list 6 510(k) clearances for Surgical Instrument Service and Savings Inc.(Dba Medline Ren, from to . As of , FDA records show 4 recalls naming K153745.

Clearance record

Decision date
Received
(125 days to decision)
Product code
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Surgical Instrument Service and Savings Inc.(Dba Medline Ren 2747 SW 6th St., Redmond OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUJ

Trailing 12 months

FDA records hold no clearances under product code NUJ in the trailing twelve months.

FDA records show no clearances under product code NUJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NUJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260