Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0 - Insighters™ Insight Workstation iS-PF1.
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Insight Workstation EUDAMED
- Device Name
- Insight Workstation EUDAMED
- Model / Reference
- iS-PF1, iS-PF2 EUDAMEDiS-PF2 EUDAMED17-237 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970831727305 EUDAMED06970831727299 EUDAMED
- Basic UDI-DI
- 697083172PF27 EUDAMED
- Direct Marketing DI
- 06970831727305 EUDAMED06970831727299 EUDAMED
- 510(k) Number
- K242793 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
- Models / Variants
- Insighters™ Insight Workstation iS-PF1. FDA 510(k)EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Insight Bimodel-Integral Bronchoscope is a single-use flexible bronchoscope designed for diagnostic and therapeutic procedures within the respiratory tract. It combines imaging and working channels to facilitate visualization and intervention, such as biopsy or airway clearance, in the trachea, bronchi, and peripheral lung regions. The device is categorized under the Ear, Nose, and Throat (ENT) classification and is intended for use in bronchoscopy applications. Its integrated design allows simultaneous imaging and procedural access, enhancing procedural efficiency and safety.
The bronchoscope models (iS-B12A, iS-B22A, iS-B26A) are supplied sterile and intended for single-use only, with varying outer diameters (4.6mm/2.0mm, 5.5mm/2.6mm, 6.0mm/3.0mm) to accommodate different patient anatomies and procedural needs. The Insight Workstation iS-PF1 is paired for use with these scopes, providing processing and imaging support. All devices are authorized under FDA 510(k) clearance and EU Medical Device Regulation (MDR), ensuring compliance with regulatory standards for medical imaging and procedural devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242793 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Insighters Medical Technology Co., Ltd.
Sources (3)
- FDA 510(k) K242793 24 fields · synced Sep 18, 2026
- EUDAMED 8090d81d-7aad-44a7-882c-b485707f5780 61 fields · synced Jul 11, 2026
- EUDAMED b3d6ec5e-c101-4972-9330-d87b86334263 61 fields · synced Jul 16, 2026