Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai SeeGen Photoelectric Technology Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
265 daysmedian FDA review time
461 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252457 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2026-01-30 | 178 | 0 |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video- | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2025-03-07 | 112 | 0 |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2024-10-22 | 145 | 0 |
| K222499 | Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-11-22 | 461 | 0 |
| K222261 | Flexible Video-Choledochoscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-04-20 | 266 | 0 |
| K211686 | Flexible Video-Choledo-Cysto-Ureteroscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2022-02-22 | 265 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda