510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191231Substantially Equivalent

Andorate Auxiliary Water Connector, Andorate Valves Set

Smartdata Suzhou Co., Ltd, Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191231 is the FDA 510(k) clearance record for Andorate Auxiliary Water Connector, Andorate Valves Set, a class II device, cleared for Smartdata Suzhou Co., Ltd. on under FDA product code ODC (Endoscope Channel Accessory). FDA's definition for product code ODC reads: "To give the endoscope channel additional or improved functionality". FDA records list 4 510(k) clearances for Smartdata Suzhou Co., Ltd., from to . As of , FDA records show no recalls naming K191231.

Clearance record

Decision date
Received
(30 days to decision)
Product code
ODC Endoscope Channel Accessory
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Smartdata Suzhou Co., Ltd. 4f, Block 7, 198#, Jinshan Rd., Suzhou, CN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code ODC

Trailing 12 months
1 clearance under product code ODC in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ODC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260