MicroSurgical Technology Inc
Redmond, WA, US
MICROSURGICAL TECHNOLOGY, INC. appears in FDA device records in Redmond, WA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for MicroSurgical Technology Inc between 1984 and 1995. The busiest year on record is 1985, with 3. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 3 |
| 1994 | 3 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953959 | PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES | HQC | Substantially Equivalent | |
| K946194 | WEE BAG O'MERCURY | LCC | Substantially Equivalent | |
| K943672 | PHACO NEEDLES AND TIPS | HQC | Substantially Equivalent | |
| K942403 | INFUSION CANNULA | HMX | Substantially Equivalent | |
| K934844 | INTER TIP T | HMX | Substantially Equivalent | |
| K854402 | THE NEW MCINTYRE I.A. HANDPIECE | HMX | Substantially Equivalent | |
| K854401 | THE NEW MOBILE TIP MCINTYRE CANNULA | HMX | Substantially Equivalent | |
| K853777 | THE NEW MCINTYRE CANNULA | HMX | Substantially Equivalent | |
| K840442 | STERILIZED DISPOS. CYSTOTOME | HMX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3019924 | 3019924 | MICROSURGICAL TECHNOLOGY, INC. | 8415 154TH AVE NE, Redmond, WA 98052 US | 2026 | and 25 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered
- LCCApplicator, Ocular Pressure
- OHWBurr, Corneal, Battery Powered, Rust Ring Removal
- HOECaliper, Ophthalmic
- HMXCannula, Ophthalmic
- HOXChart, Visual Acuity
- HOCClip, Iris Retractor
- HNZCurette, Ophthalmic
- HNYCystotome
- HNXDepressor, Orbital
- KYGDevice, Irrigation, Ocular Surgery
- HNWDilator, Lachrymal
- KKXDrape, Surgical, Antimicrobial
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- OJKEye Tray
- HNRForceps, Ophthalmic
- HNQHook, Ophthalmic
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HNNKnife, Ophthalmic
- HMRMarker, Ocular
- HNMNeedle, Ophthalmic Suturing
- GDLNeedle, Suturing, Reusable
- HONPerimeter, Manual
- MRHPump, Infusion, Ophthalmic
- BTAPump, Portable, Aspiration (Manual Or Powered)
- HNJPunch, Corneo-Scleral
- HNIRetractor, Ophthalmic
- HNHRing, Ophthalmic (Flieringa)
- HNFScissors, Ophthalmic
- HNDSpatula, Ophthalmic
- HNCSpecula, Ophthalmic
- HOZSponge, Ophthalmic
- HNBSpoon, Ophthalmic
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- FSMTray, Surgical, Instrument
- HQCUnit, Phacofragmentation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0411-2026 | MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01 | An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation | Class II | Open, Classified | |
| Z-0521-2025 | Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads. | Due to pin coming off of handles. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain