Clearance Summary
BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE received FDA 510(k) clearance under submission number K932771, sponsored by Xomed-Treace, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1994-08-24.
- Submission: K932771
- Applicant / Sponsor: Xomed-Treace, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4350
- Decision date: 1994-08-24
Classification & Regulation
This clearance is catalogued under FDA product code EQH and 21 CFR 874.4350, within the Ear, Nose, Throat review panel as a Class I device.