Clearance Summary
EPISTAXIS NASAL BALLOON CATHETER received FDA 510(k) clearance under submission number K921199, sponsored by Smith & Nephew Richards, 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 1992-07-08.
- Submission: K921199
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4100
- Decision date: 1992-07-08
Classification & Regulation
This clearance is catalogued under FDA product code EMX and 21 CFR 874.4100, within the Ear, Nose, Throat review panel as a Class I device.