Clearance Summary
KARL STORZ TWIN TRANSILLUMINATOR received FDA 510(k) clearance under submission number K962032, sponsored by KARL STORZ Endoscopy-America, 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 1996-07-05.
- Submission: K962032
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4350
- Decision date: 1996-07-05
Classification & Regulation
This clearance is catalogued under FDA product code MQW and 21 CFR 874.4350, within the Ear, Nose, Throat review panel as a Class I device.