510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912839Substantially Equivalent

Laparooptx(tm) Intraoper Deflect Choledochoscope

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

K912839 is the FDA 510(k) clearance record for LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE, a class I device, cleared for Baxter Healthcare Corp on under FDA product code FBW (Filiform And Filiform Follower). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K912839.

Clearance record

Decision date
Received
(91 days to decision)
Product code
FBW Filiform And Filiform Follower
Regulation
21 CFR 876.5520
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 2132 Michelson Dr., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code FBW

Trailing 12 months

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

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