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K243535Substantially Equivalent

Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

Shanghai Seegen Photoelectric Technology Co., Ltd, Shanghai, CN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243535 is the FDA 510(k) clearance record for Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U), a class II device, cleared for Shanghai SeeGen Photoelectric Technology 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 6 510(k) clearances for Shanghai SeeGen Photoelectric Technology Co., Ltd., from to . As of , FDA records show no recalls naming K243535.

Clearance record

Decision date
Received
(112 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
Shanghai SeeGen Photoelectric Technology Co., Ltd. 3 Floor, Bldg. #1, 4299 Jindu Rd. Minhang District, Shanghai, 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