510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905552Substantially Equivalent

Laparolith

Baxter Healthcare Corporation, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905552 is the FDA 510(k) clearance record for LAPAROLITH, a class II device, cleared for Baxter Healthcare Corp on under FDA product code LQC (Lithotriptor, Biliary Mechanical). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K905552.

Clearance record

Decision date
Received
(371 days to decision)
Product code
LQC Lithotriptor, Biliary Mechanical
Regulation
21 CFR 876.4500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 2132 Michelson Dr., Irvine CA
Third party review
No

Clearances, product code LQC

Trailing 12 months

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

FDA records show no clearances under product code LQC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQC, 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