DEFENDO Bronchoscopy Suction Valve
FDA 510(k) K151522 · Medivators, Inc.
510(k) numberK151522
Submission
- Device name
- DEFENDO Bronchoscopy Suction Valve
- Applicant
- Medivators, Inc.
Conroe, TX, US - Received
- June 5, 2015
- Decision date
- September 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTI – Bronchoscope Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was DEFENDO Bronchoscopy Suction Valve cleared by the FDA?
DEFENDO Bronchoscopy Suction Valve (K151522) received a 510(k) decision of Substantially Equivalent on September 17, 2015, 104 days after the submission was received.
What is the product code of K151522?
The FDA product code is KTI – Bronchoscope Accessory, a Class II (moderate risk) device regulated under 21 CFR 874.4680.