510(k) K133921
K133921 is an FDA 510(k) premarket notification submitted by Preceptis Medical for the device "PRECEPTIS TYMPANOSTOMY TUBE INSERTER". The FDA issued a decision of Substantially Equivalent on August 22, 2014. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Preceptis Medical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2014
- Date Received
- December 23, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tympanostomy
- Device Class
- Class II
- Regulation Number
- 874.3880
- Review Panel
- EN
- Submission Type