510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241224Substantially Equivalent

Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

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)

K241224 is the FDA 510(k) clearance record for Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT), a class II device, cleared for Surgical Instrument Service and Savings Inc.(Dba Medline Ren on under FDA product code NLH (Catheter, Recording, Electrode, Reprocessed). FDA's definition for product code NLH 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 2 recalls naming K241224.

Clearance record

Decision date
Received
(197 days to decision)
Product code
NLH Catheter, Recording, Electrode, Reprocessed
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Surgical Instrument Service and Savings Inc.(Dba Medline Ren 1500 NE Hemlock Ave., Redmond OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLH

Trailing 12 months
1 clearance under product code NLH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NLH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260