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Shenzhen Insighters Medical Technology Co., Ltd.
FDA Regulatory Profile
Shenzhen Insighters Medical Technology Co., Ltd. appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 28, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K242793 | Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use | May 28, 2025 |
| K232529 | Disposable Double Lumen Endobronchial Tube | May 13, 2024 |
| K232580 | Disposable Endobronchial Blocker Tube | December 14, 2023 |