Clearance Summary
SHURE GRIP TYING FORCEPS received FDA 510(k) clearance under submission number K844129, sponsored by Mentor O & O, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-11-21.
- Submission: K844129
- Applicant / Sponsor: Mentor O & O, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1984-11-21
Classification & Regulation
This clearance is catalogued under FDA product code HNR and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.