Shanghai SeeGen Photoelectric Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Shanghai SeeGen Photoelectric Technology Co., Ltd.” (first 2022, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 222 days. Since 2017 the median was 222 days, against 140 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 265 |
| 2023 | 2 | 364 |
| 2024 | 1 | 145 |
| 2025 | 1 | 112 |
| 2026 | 1 | 178 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shanghai SeeGen Photoelectric Technology Co., Ltd. took a median 222 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 2 | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
Most recent Shanghai SeeGen Photoelectric Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252457 | Disposable Distal End Tape Hood | FDF | 2026-01-30 | 178 |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | FBN | 2025-03-07 | 112 |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | FET | 2024-10-22 | 145 |
| K222499 | Disposable Endoscope Valves Kit | ODC | 2023-11-22 | 461 |
| K222261 | Flexible Video-Choledochoscope System | FBN | 2023-04-20 | 266 |
| K211686 | Flexible Video-Choledo-Cysto-Ureteroscope System | FGB | 2022-02-22 | 265 |
Recalls
openFDA lists no recalls under a recalling firm named Shanghai SeeGen Photoelectric Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
- Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
- Shanghai Antares Industries, Inc. (14 510(k)s)
- Shanghai Apolo Medical Technology Co., Ltd. (14 510(k)s)
- Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
- Shanghai Sanyou Medical Co, Ltd. (9 510(k)s)
- Shanghai Chenguang Medical Technologies Co, Ltd. (8 510(k)s)
- Shanghai Motex Healthcare Co., Ltd. (8 510(k)s)
- Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
- Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
- Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanghai SeeGen Photoelectric Technology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Shanghai SeeGen Photoelectric Technology Co., Ltd.” (first 2022, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shanghai SeeGen Photoelectric Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai SeeGen Photoelectric Technology Co., Ltd. is 222 days. Since 2017: 222 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shanghai SeeGen Photoelectric Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are FBN (Choledochoscope And Accessories, Flexible/Rigid, 2); FDF (Colonoscope And Accessories, Flexible/Rigid, 1); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 1).
Next steps
- See all 6 Shanghai SeeGen Photoelectric Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FBN, Shanghai SeeGen Photoelectric Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.