Clearance Summary
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME received FDA 510(k) clearance under submission number K874993, sponsored by Advanced Surgical Products, 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 1988-04-13.
- Submission: K874993
- Applicant / Sponsor: Advanced Surgical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1988-04-13
Classification & Regulation
This clearance is catalogued under FDA product code HNY and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.