510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K903709Substantially Equivalent

Surgimedics, Slp Laparoscopic Cholangiogram Cath

Lifestream Int'L, Inc., The Woodlands TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903709 is the FDA 510(k) clearance record for SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH, a class I device, cleared for Lifestream Int'L, Inc. on under FDA product code GBZ (Catheter, Cholangiography). FDA records list 23 510(k) clearances for Lifestream Int'L, Inc., from to . As of , FDA records show no recalls naming K903709.

Clearance record

Decision date
Received
(71 days to decision)
Product code
GBZ Catheter, Cholangiography
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Lifestream Int'L, Inc. 2828 N.Crescent River Dr., The Woodlands TX
Third party review
No

Clearances, product code GBZ

Trailing 12 months

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

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