510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231497Substantially Equivalent

Choledochoscope System

Shenzhen Hugemed Medical Technical Development Co., Ltd, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231497 is the FDA 510(k) clearance record for Choledochoscope System, a class II device, cleared for Shenzhen HugeMed Medical Technical Development Co., Ltd. on under FDA product code FBN (Choledochoscope And Accessories, Flexible/Rigid). FDA's definition for product code FBN reads: "to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807...". FDA records list 8 510(k) clearances for Shenzhen HugeMed Medical Technical Development Co., Ltd., from to . As of , FDA records show no recalls naming K231497.

Clearance record

Decision date
Received
(287 days to decision)
Product code
FBN Choledochoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd. 415, 416-1, 516-1, Bldg. 2, # 1, Mawu Rd., Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FBN

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