MicroSurgical Technology Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 9
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0411-2026 | Class II | MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48 | August 20, 2025 |
| Z-0521-2025 | Class II | Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single | September 17, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K953959 | PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES | November 17, 1995 |
| K946194 | WEE BAG O'MERCURY | February 27, 1995 |
| K943672 | PHACO NEEDLES AND TIPS | October 13, 1994 |
| K942403 | INFUSION CANNULA | August 17, 1994 |
| K934844 | INTER TIP T | April 19, 1994 |
| K854401 | THE NEW MOBILE TIP MCINTYRE CANNULA | December 30, 1985 |
| K854402 | THE NEW MCINTYRE I.A. HANDPIECE | December 30, 1985 |
| K853777 | THE NEW MCINTYRE CANNULA | November 21, 1985 |
| K840442 | STERILIZED DISPOS. CYSTOTOME | March 16, 1984 |