Data / Medical devices / United States / Microsurgical Technology, Inc.

Microsurgical Technology, Inc.: FDA-registered device maker in Redmond, WA, United States, 7 510(k) clearances

Name: Microsurgical Technology, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Microsurgical Technology, Inc. is registered with the FDA (registration 3019924) in Redmond, WA, United States. It lists 35 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 8, 2022. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3019924
Address: 8415 154TH Ave Ne, Redmond, WA, United States, 98052
Owner or operator: MicroSurgical Technology (3019924)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: October 11, 1979
Registered through: 2027
Brand names listed: AccuSharp Disposable Ophthalmic Knife, AccuSurgical Eye Spears, Accusurgical, Accusurgical Cystotome, Accusurgical Ophthalmic Cannulas, Accusurgical Spatula, Accutome, Accutome Ophthalmic Forceps and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Cautery, Radiofrequency, Ac-Powered	HQR	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Burr, Corneal, Battery Powered, Rust Ring Removal	OHW	1	Repackager or relabeler	accessdata.fda.gov
Caliper, Ophthalmic	HOE	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Chart, Visual Acuity	HOX	1	Repackager or relabeler	accessdata.fda.gov
Clip, Iris Retractor	HOC	1	Manufacturer	accessdata.fda.gov
Curette, Ophthalmic	HNZ	1	Repackager or relabeler	accessdata.fda.gov
Cystotome	HNY	1	Repackager or relabeler	accessdata.fda.gov
Depressor, Orbital	HNX	1	Repackager or relabeler	accessdata.fda.gov
Device, Irrigation, Ocular Surgery	KYG	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Dilator, Lachrymal	HNW	1	Repackager or relabeler	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Eye Tray	OJK	2	Repackager or relabeler	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-Powered	HQE	2	Contract manufacturer	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Manufacturer, Specification developer	accessdata.fda.gov
Marker, Ocular	HMR	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Needle, Ophthalmic Suturing	HNM	1	Manufacturer	accessdata.fda.gov
Needle, Suturing, Reusable	GDL	1	Repackager or relabeler	accessdata.fda.gov
Perimeter, Manual	HON	1	Repackager or relabeler	accessdata.fda.gov
Pump, Infusion, Ophthalmic	MRH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Punch, Corneo-Scleral	HNJ	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Ophthalmic	HNI	1	Manufacturer	accessdata.fda.gov
Ring, Ophthalmic (Flieringa)	HNH	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Manufacturer	accessdata.fda.gov
Spatula, Ophthalmic	HND	1	Repackager or relabeler	accessdata.fda.gov
Specula, Ophthalmic	HNC	1	Repackager or relabeler	accessdata.fda.gov
Sponge, Ophthalmic	HOZ	2	Repackager or relabeler	accessdata.fda.gov
Spoon, Ophthalmic	HNB	1	Repackager or relabeler	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Unit, Phacofragmentation	HQC	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 8, 2022	K213173	TrabEx Pro	MRH	Substantially Equivalent	Microsurgical Technologies, Inc.	accessdata.fda.gov
October 2, 2006	K062366	OPTIME, SINUSORB PGA	GAM	Substantially Equivalent	Peters Surgical	accessdata.fda.gov
May 18, 2006	K061258	TRABECTOME HIGH FREQUENCY GENERATOR/LP	GEI	Substantially Equivalent	Neomedix Corp.	accessdata.fda.gov
May 17, 2005	K050322	MICROTEK EQUIPMENT DRAPES	KKX	Substantially Equivalent	Microtek Medical, Inc.	accessdata.fda.gov
April 22, 2004	K040584	NMX-1000	GEI	Substantially Equivalent	Neomedix Corp.	accessdata.fda.gov
February 17, 2004	K040239	SUPRAFLOW CONSOLE	BTA	Substantially Equivalent	Neomedix Corp.	accessdata.fda.gov
October 13, 1994	K943672	PHACO NEEDLES AND TIPS	HQC	Substantially Equivalent	Microsurgical Technology, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 20, 2025	97470	Class II	Ongoing	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	accessdata.fda.gov
September 17, 2024	95572	Class II	Ongoing	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 U	Due to pin coming off of handles.	accessdata.fda.gov

Compare with other makers

Updated October 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.