510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202838Substantially Equivalent

Andorate Universal Endoscope Tip Guard

GA Health Company Limited, Hong Kong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202838 is the FDA 510(k) clearance record for Andorate Universal Endoscope Tip Guard, a class II device, cleared for Ga Health Company Limited on under FDA product code OCU (Endoscopic Storage Cover). FDA's definition for product code OCU reads: "To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization". FDA records list 12 510(k) clearances for Ga Health Company Limited, from to . As of , FDA records show no recalls naming K202838.

Clearance record

Decision date
Received
(161 days to decision)
Product code
OCU Endoscopic Storage Cover
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ga Health Company Limited Unit 18, 21/F, Metropole Sq., 2 On Yiu St., Shatin, Hong Kong, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCU

Trailing 12 months

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

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