Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1929756

FEI Number

1929756

Entity Name

ANODYNE SURGICAL

City/State/Country

O Fallon, MO, US

Establishment Address

804 Corporate Centre Dr, O Fallon, MO 63368, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PSI/EYE-KO, INC. (Owner Number: 1929756)

Owner / Operator Contact Address

804 CORPORATE CENTRE DR., --, O Fallon, MO 63368, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Anodyne Surgical Tray, Surgical Capsulorhexis Irrigating STILETTO AND SINGLE EDGE KNIFES Anodyne Surgical Scissors, Ophthalmic SIMCOLE LENS LOOP RAIN IRIS MICRO LENS Non Atkinson Atkinson Retrobulbar Needles Peribulbar Needles Anodyne Surgical PVA Spears Non Atkinson Atkinson Peribulbar Retrobulbar Surgical Eye Tray, Forsight Kit KRATZ BARRAQUER wire solid blade Child pediatric Anodyne Surgical Marker, ocular Anodyne Surgical Forceps, ophthalmic Anodyne Surgical Caliper, ophthalmic IMA Cannula SQUEEGEE BOWMAN PIGTAIL PROBE W/SUTURE CRAWFORD/CATLANO INTUBATION PROBE, LACHRYMAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-07-18
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2010-11-12
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-04
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-07-18
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2019-05-02
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-04
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-04
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	1993-01-04
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2022-05-04
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	1993-01-04
PZG	Surgical Eye Tray	Ophthalmic	Class 1	886.4350	2023-12-27
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-04
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2023-07-18
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-07-20
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-07-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-02-06
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2010-11-12
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1993-01-04

Official Correspondent

Valerie Anderson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PSI/EYE-KO, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1929756. Last updated year: 2026. Please use registration number 1929756 when referencing this establishment in official correspondence.