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KATALYST SURGICAL, LLC

Last updated September 17, 2026

What KATALYST SURGICAL, LLC makes

Katalyst Surgical, LLC manufactures ophthalmic surgical instruments including soft-tissue manipulation forceps, surgical probes, irrigation/infusion/aspiration cannulas, knives, and bone curettes. Their product range includes both reusable and single-use devices such as titanium lens folding forceps, Spetzler lighted suction tubes, and various keratome lancets.

The company's portfolio includes Class I and Class II medical devices, which are listed in the FDA Unique Device Identification (UDI) registry. Katalyst Surgical is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Katalyst Surgical, LLC manufacture?

Katalyst Surgical, LLC manufactures ophthalmic surgical instruments including soft-tissue manipulation forceps, surgical probes, irrigation/infusion/aspiration cannulas, knives, and bone curettes. Their products include both reusable and single-use devices such as titanium lens folding forceps and Spetzler lighted suction tubes.

Where is Katalyst Surgical, LLC based?

Katalyst Surgical, LLC is based in the United States. The company operates within the US, manufacturing and distributing ophthalmic surgical instruments to healthcare facilities and professionals.

Which regulatory registries list Katalyst Surgical's devices?

Katalyst Surgical's devices are listed in the FDA Unique Device Identification (UDI) registry. This registry tracks medical devices through their unique identifiers, ensuring proper identification and tracking throughout their lifecycle.

How are Katalyst Surgical's devices classified?

Katalyst Surgical's devices are classified as Class I and Class II medical devices. Class I devices pose the lowest risk and are subject to general controls, while Class II devices require special controls in addition to general controls to ensure their safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 754 Goddard ave, Chesterfield, MO, 63005
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007589150
DUNS Number: —

Catalogue (2234)

Page 27 of 45

Device	Model / Reference	Registries	Class	Status
GemcisionTM Keratome Lancet, Super Sharp, Sharp Sides, 2.8mm Width/Box of 5	7924-K28b	FDA UDI	Class I	Unknown
Flieringa Scleral Fixation Ring, 19mm	8800-19	FDA UDI	Class I	Active
27ga Stiff MultiFlex Inverted Extendable Laser Probe, Dorc Connector	V6520E-27J	FDA UDI	Class II	Active
Titanium Irrigating Luer Handle	4011	FDA UDI	Class I	Active
23ga iQ™ Kamei Sweeper Forceps	RVF4025-23	FDA UDI	Class I	Active
Gemcision™ Keratome Lancet, Super Sharp, 2.5mm Width/Box of 5	7920-K25b	FDA UDI	Class I	Unknown
Titanium Universal Akahoshi Prechopper, Straight	3572-120R	FDA UDI	Class I	Active
Titanium Fenzel Insertion Hook, Straight	20002S	FDA UDI	Class I	Active
25ga Dex™ Asymmetrical ILM Forceps	DVF4014-25	FDA UDI	Class I	Active
25ga Illuminated Infusion Cannula	V2201-25	FDA UDI	Class II	Unknown
Koch Stop and Chop Manipulator, STAINLESS STEEL	5500A	FDA UDI	Class I	Active
Disposable Irrigating Bipolar Forceps, 9", 0.5mm Straight Tips	DNI9-05S	FDA UDI	Class II	Active
27ga ISOCLEAN™ Curved Horizontal Scissors	VS5006-27	FDA UDI	Class I	Active
Stainless Steel Graefe Strabismus Hook, 8mm	2010-8	FDA UDI	Class I	Active
25ga Stiff Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector	V6352-25AR	FDA UDI	Class II	Unknown
23ga Dex™ Holekamp Anatomical ILM Forceps	DVF4011-23	FDA UDI	Class I	Unknown
20ga Shielded Widefield Light Pipe	V2011-20V	FDA UDI	Class II	Unknown
Kogent KoAg™ Disposable Spetzler™ Illuminated Bipolar Forceps, 7", 1.5mm, Straig	DNL7-15S	FDA UDI	Class II	Active
20ga Dex™ Curved ILM Forceps	DVF4010-20	FDA UDI	Class I	Unknown
23ga Diamondless Brush Polisher	DV1001-23	FDA UDI	Class I	Active
27ga Poly Polisher	DV1003-27	FDA UDI	Class I	Active
27ga ISOCLEAN™ NanoTapered™ Awh Forceps, Gold	VF4005-27G	FDA UDI	Class I	Active
Ciliprobe Transsceral Cyclophotocoagulation Probe	D4700A	FDA UDI	Class II	Active
23ga Dex™ Invisible™ Forceps	DVF4027-23	FDA UDI	Class I	Unknown
Elevator, Bayonet Handle, Curved Up, 185mm	N2601	FDA UDI	Class I	Active
25ga Dex Tips™ NanoTapered™ Duckbill Forceps	CVF4017-25	FDA UDI	Class I	Unknown
23ga ISOCLEAN™ Mason Curved Horizontal Scissors	VS5003-23	FDA UDI	Class I	Active
25ga Dex™ Holekamp Forceps	DVF4006-25	FDA UDI	Class I	Unknown
20ga Retractable Tano™ Polisher	DV1024-20	FDA UDI	Class I	Active
25ga Tapered Flexible Curved Laser Probe, Iridex	V6100-25A	FDA UDI	Class II	Active
Disposable Bipolar Forceps, 7", 1.0mm Straight Tips	DNK7-10S	FDA UDI	Class II	Active
Titanium Drysdale Nucleus Manipulator, Sharp Edge, Angled	2503S	FDA UDI	Class I	Active
27ga Dex™ NanoTapered™ Awh Forceps	DVF4005-27	FDA UDI	Class I	Active
Air Injection Cannula, 27ga	1000-27	FDA UDI	Class I	Active
Spetzler Reusable Micro Scissors, Straight 8-inch, Round Handle, Curved Tips	N6212	FDA UDI	Class I	Active
Seibel Nucleus Chopper and Safety Quick Chop, Double Ended, Left	5516-L	FDA UDI	Class I	Active
23ga iQ™ Serrated Forceps, Gold	RVF4016-23G	FDA UDI	Class I	Active
GemcisionTM 600 Micron Blade, LRI	7950-L600	FDA UDI	Class I	Active
Disposable KoAg Bipolar Forceps, 9", 0.5mm Straight Tips, Box of 5	DNN9-05S	FDA UDI	Class II	Active
Titanium Helveston Retractor, 7mm	4450-7	FDA UDI	Class I	Active
Capsule Polishing Curette	1601	FDA UDI	Class I	Active
Ball Tip Probe, Angled 45°, Straight Handle, 185mm \| Medtronic	N2702	FDA UDI	Class I	Active
Spetzler® Micro Dissection Set, Tray #2	N079-SET	FDA UDI	Class I	Active
20ga Endo-Ocular Probe-Straight	XLEND20D	FDA UDI	Class II	Active
Ring Curette, Angled Up 45 2.25mm Dia. Ring, Bayonet Round Handle, 210mm\|Kogent	N2401-K	FDA UDI	Class I	Active
23ga Retractable Tano™ Polisher	DV1024-23	FDA UDI	Class I	Active
Titanium Lester Lens Manipulator, Straight	2501S	FDA UDI	Class I	Active
Titanium Phaco Chopper, 45° Offset	5508	FDA UDI	Class I	Active
6-S™ Drysdale Nucleus Manipulator, Carbon Fiber Handle, Left	2503A-6L	FDA UDI	Class I	Active
23ga DEX™ EZPeel Forceps	DVF4037-23	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Katalyst Surgical, LLC has 12 recall records, all initiated on 2026-03-25, with statuses recorded as open and classified. The reasons given include Ophthalmic Tissue Forceps (DEX") being sterile, hand-held ophthalmic surgical devices under GMDN code 62478, and a Field Safety Corrective Action for Instructions for Use (IFU) in DEX Forceps and Scissors.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 25, 2026	Z-2074-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2076-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2071-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2077-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2080-2026	—	open, classified	Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
Mar 25, 2026	Z-2069-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2078-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2075-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2079-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2072-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2070-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Mar 25, 2026	Z-2073-2026	—	open, classified	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.