510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905459Substantially Equivalent

Surgical Procedure Tray/laparoscopy Cholecystectom

Angiosystems, Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905459 is the FDA 510(k) clearance record for SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM, a class II device, cleared for Angiosystems, Inc. on under FDA product code LRO (General Surgery Tray). FDA's definition for product code LRO reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 14 510(k) clearances for Angiosystems, Inc., from to . As of , FDA records show no recalls naming K905459.

Clearance record

Decision date
Received
(121 days to decision)
Product code
LRO General Surgery Tray
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Angiosystems, Inc. C/O Medical Device Inspeciton, Great Neck NY
Third party review
No

Clearances, product code LRO

Trailing 12 months

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

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