Disposable Distal End Tape Hood— 510(k) K252457
Substantially EquivalentShanghai SeeGen Photoelectric Technology Co., Ltd.
FDA 510(k) clearance K252457 for Disposable Distal End Tape Hood, Substantially Equivalent on 2026-01-30. Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai SeeGen Photoelectric Technology Co., Ltd.
- Product code
- Code FDF
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code FDF
view allMore clearances from Shanghai SeeGen Photoelectric Technology Co., Ltd.
view all- K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
- K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
- K222499 — Disposable Endoscope Valves Kit
- K222261 — Flexible Video-Choledochoscope System
- K211686 — Flexible Video-Choledo-Cysto-Ureteroscope System
Adverse events under product code FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.