510(k) K142022
K142022 is an FDA 510(k) premarket notification submitted by Medline Renewal for the device "MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code NLY (Microdebrider, Ent, High Speed, Single Use, Reprocessed), a Class I device regulated under 21 CFR 874.4140.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2014
- Date Received
- July 25, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microdebrider, Ent, High Speed, Single Use, Reprocessed
- Device Class
- Class I
- Regulation Number
- 874.4140
- Review Panel
- EN
- Submission Type
ENT microdebrider is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nost and throat surgery. These devices operate at high speed for precise tissue resection. (this is for reprocessed sing use ENT microdebrider.)