510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Shanghai Seegen Photoelectric Technology Co., Ltd

Shanghai, CN

SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD appears in FDA device records in Shanghai, CN. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 6 510(k) clearances for Shanghai Seegen Photoelectric Technology Co., Ltd between 2022 and 2026. The busiest year on record is 2023, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Shanghai Seegen Photoelectric Technology Co., Ltd, by decision year
YearClearances
20221
20232
20241
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252457Disposable Distal End Tape HoodFDFSubstantially Equivalent
K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)FBNSubstantially Equivalent
K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)FETSubstantially Equivalent
K222499Disposable Endoscope Valves KitODCSubstantially Equivalent
K222261Flexible Video-Choledochoscope SystemFBNSubstantially Equivalent
K211686Flexible Video-Choledo-Cysto-Ureteroscope SystemFGBSubstantially Equivalent

Registered establishments

FDA registered establishments for Shanghai Seegen Photoelectric Technology Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30221065663022106566SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD3 Floor, Building No.1, 4299 JinDu Road, Shanghai 201108 CN2026
30280588433028058843SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTDBuilding No.5, 4277 YinDu Road, Minhang District, 201108 Shanghai, PEOPLE'S REPUBLIC OF CHINA, Shanghai 201108 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain