510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960787Substantially Equivalent

Tur,arthroscopic,cystoscopy Irrigation Sets

Baxter Healthcare Corporation, Round Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960787 is the FDA 510(k) clearance record for TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS, a class II device, cleared for Baxter Healthcare Corp on under FDA product code LJH (System, Irrigation, Urological). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show 4 recalls naming K960787.

Clearance record

Decision date
Received
(78 days to decision)
Product code
LJH System, Irrigation, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp Rt. 120 & Wilson Rd., Round Lake IL
510(k) summary
Summary
Third party review
No

Clearances, product code LJH

Trailing 12 months
1 clearance under product code LJH in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJH, 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 20261
October 20260