FDA 510(k) K241612, Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2), by Hunan Vathin Medical Instrument Co., Ltd.
FDA 510(k) K241612, Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2), by Hunan Vathin Medical Instrument Co., Ltd.
FDA 510(k) records for Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) (K241612), submitted by Hunan Vathin Medical Instrument Co., Ltd..
- 510(k) Number: K241612
- Device Classification: Bronchoscope (Flexible Or Rigid)
- Applicant: Hunan Vathin Medical Instrument Co., Ltd.
- Date Received: 06/05/2024
- Decision Date: 10/29/2024
- Decision: Substantially Equivalent (SESE)
- Regulation Number: 874.468
- Product Code: EOQ
- Regulation Medical Specialty: Ear Nose & Throat
- Review Panel: Ear Nose & Throat
- Total Pages: 4486 (3674 unredacted, 18% redacted overall)
What's in this document (sections may appear in any order):
- ✗ 510(k) Summary / Statement: 100% redacted
- ✗ Indications for Use: 72% redacted
- ✗ Device Description: 73% redacted
- ✗ Substantial Equivalence / Predicate: 71% redacted
- ✗ Performance / Bench Testing: 70% redacted
- ✗ Biocompatibility: 84% redacted
- ✗ Software / Cybersecurity: 82% redacted
- ~ Sterilization / Shelf Life: 45% redacted
- ✗ Labeling / IFU: 77% redacted
- ✗ Clinical Data: 100% redacted
- ~ FDA Correspondence: 50% redacted
- ✗ Risk Analysis / FMEA: 66% redacted
- ✗ Electromagnetic Compatibility (EMC): 71% redacted
Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.
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