Defendo Bronchoscopy Suction Valve
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- DEFENDO EUDAMEDFDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- Defendo Valves Kit EUDAMEDDefendo for Fuji 700, 3-piece Single Use Valve Kit with Air Water, Suction, and Biopsy Valve. FDA UDIDefendo for Fuji 700, 4-piece Single Use Valve Kit with Air Water, Suction, Biopsy Valve, Cleaning Adapter FDA UDI
- Model / Reference
- Defendo Valves Kit EUDAMED100328 EUDAMED100335 EUDAMEDDefendo Fujifilm 700 Series FDA UDI
- Description
- Defendo for Fuji 700, 3-piece Single Use Valve Kit with Air Water, Suction, and Biopsy Valve. FDA UDIDefendo for Fuji 700, 4-piece Single Use Valve Kit with Air Water, Suction, Biopsy Valve, Cleaning Adapter FDA UDI
Identifiers
- Catalog Number
- 100335 FDA UDI100328 FDA UDI
- Primary DI / UDI-DI
- 00724995228958 EUDAMEDFDA UDI00724995228910 EUDAMEDFDA UDI
- Basic UDI-DI
- 0724995CODEFENDVLKITF8 EUDAMED
- FDA Product Code
- KTI FDA 510(k)ODC FDA UDIFDF FDA UDIFEQ FDA UDI
- EMDN Code
- A030499 ADMINISTRATION KITS - OTHER EUDAMED
- GMDN Term
- Endoscope channel support kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)876.1500 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The Defendo Bronchoscopy Suction Valve is a bronchoscope accessory designed to regulate suction during pulmonary procedures. It acts as a disposable valve to control airflow and suction pressure, ensuring safe and efficient operation of compatible bronchoscopes.
This device is supplied as a single-use, non-sterile component intended for use in ear, nose, and throat (ENT) procedures. It is classified as a Class II medical device under FDA regulations (21 CFR 874.4680) and has received FDA 510(k) clearance (K151522) and MDR authorization. No specific MRI safety classification or sterility requirements are noted in the provided data.
Frequently asked questions
What is the primary purpose of the Defendo Bronchoscopy Suction Valve during pulmonary procedures?
The Defendo Bronchoscopy Suction Valve is designed as a disposable accessory to regulate airflow and suction pressure during bronchoscopy procedures. It ensures safe and efficient operation by controlling suction, which helps maintain stability and reduce complications during ENT-related pulmonary interventions.
Is the Defendo Bronchoscopy Suction Valve sterile when supplied, and how should it be handled?
The Defendo Bronchoscopy Suction Valve is supplied as a non-sterile single-use component. Since it is not sterile, it should be handled in accordance with standard medical device preparation protocols, including proper cleaning of the bronchoscope attachment site before use, to minimize contamination risks.
Can this device be reused, or is it intended for single-use only?
The Defendo Bronchoscopy Suction Valve is explicitly labeled as a single-use device. Reuse is not recommended or supported by the manufacturer, as it could compromise safety, functionality, or regulatory compliance.
What regulatory pathways has the Defendo Bronchoscopy Suction Valve undergone, and which agency approved it?
The device has received FDA 510(k) clearance (K151522) under the Traditional pathway, with a decision classification of *Substantially Equivalent* to a predicate device. It is also authorized under the EU Medical Device Regulation (MDR). The clearance was granted by the FDA’s Ear, Nose, and Throat (ENT) advisory committee, confirming its compliance for use in ENT procedures.
Are there multiple sizes or models of the Defendo Bronchoscopy Suction Valve, or is it available in a single configuration?
The provided data lists multiple registration numbers and product codes (e.g., KTI) associated with the Defendo Bronchoscopy Suction Valve, suggesting there may be variations in models or configurations. However, the core function—regulating suction during bronchoscopy—remains consistent. For exact sizing or model-specific details, consult the manufacturer’s technical documentation or contact Medivators Inc.
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. Sources consulted: DEFENDO Bronchoscopy Suction Valve (K151522) — FDA 510 (k) | Innolitics, DEFENDO™ Single-Use Valves - STERIS, DEFENDO Bronchoscopy Suction Valve 510(k) K151522 - FDA.report, MAUDE Adverse Event Report: MEDIVATORS, INC. DEFENDO DISPOSABLE SUCTION ...
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 | K151522 | Class II | Active |
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Manufacturer
- Manufacturer
- Medivators Inc.
- FDA Applicant
- Medivators, Inc.
Sources (5)
- FDA 510(k) K151522 24 fields · synced Sep 18, 2026
- FDA UDI d83a59b6-070f-4891-a071-7541eec11c94 36 fields · synced May 30, 2026
- FDA UDI ff817a40-64eb-4d7c-aba8-0c5c77d1403c 36 fields · synced May 30, 2026
- EUDAMED dca6967b-6b1f-4c79-b54e-e23fb4d95a57 61 fields · synced Jul 12, 2026
- EUDAMED 31f89e9d-bf65-4121-8871-401b7b5a8060 61 fields · synced Jul 27, 2026