Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015177648

FEI Number

3015177648

Entity Name

KATENA PRODUCTS, INC.

City/State/Country

Parsippany, NJ, US

Establishment Address

6 CAMPUS DRIVE, SUITE 310, Parsippany, NJ 07054, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Corza Medical, Inc. (Owner Number: 2242450)

Owner / Operator Contact Address

2755 Canyon Boulevard, 1st Floor, Boulder, CO 80302, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053333

PMA Number

N/A

All Registered Proprietary Names

GRAETHER DuraPlug Punctal Gauge Eagle Honan Balloon multiple, needle holder names Wright Fascia Needle Diamond Knifes (multiple) Clear Corneal Diamond Knife Diamond Step Knife Diamond Knife Crescent AK Step Knife Double Footplate Tooke Corneal Knife Sharpoint Lacrimal Cannula Facial Infiltration Needle Peribulbar Needle Retrobulbar Needle MALLET STAINLESS STEEL EaglePlug TearFlow; Flow Controller Eagle Flex; EaglePlug; Plug 1; SuperEagle; SuperFlex tarSys INSTRUMENT WIPES, PVA SPONGE INSTRUMENT TIP GUARDS Blink Infant Speculum Temporal Speculum Castroviejo Lid Speculum FLIERINGA FIXATION RING MCNEILL GLOBAL FIXATION RING GASS SCLERAL MARKER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
PZG	Surgical Eye Tray	Ophthalmic	Class 1	886.4350	2019-08-28
HKS	Prism, Gonioscopic	Ophthalmic	Class 1	886.1660	2016-02-08
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2016-11-10
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-10-08
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1993-01-01
LCC	Applicator, Ocular Pressure	Ophthalmic	Class 2	886.4610	2008-03-14
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	1993-01-01
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2007-10-31
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2016-11-10
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2007-11-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-06-11
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-08-21
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2013-01-23
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-08-21
HOF	Burr, Corneal, Manual	Ophthalmic	Class 1	886.4350	1977-12-08
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2007-10-08
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-11-19
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1993-01-01
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-06-24
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	1993-01-01
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1993-01-01
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-10-08
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-10-08
NXM	Prosthesis, Eyelid Spacer/Graft, Biologic	Ophthalmic	Class 2	886.3130	2016-09-19
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1993-01-01
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-10-31
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	1993-01-01
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2018-06-12
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2007-10-31
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	1993-01-01
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2001-08-29
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2021-07-29
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Ophthalmic	Class 1	886.4070	2013-06-10
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HNG	Rongeur, Lachrymal Sac	Ophthalmic	Class 1	886.4350	2001-08-29
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	1993-01-01
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1993-01-01
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1993-01-01
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	1993-01-01
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2007-10-31
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-08-29
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1993-01-01
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1993-01-01
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	1993-01-01
HJL	Lens, Condensing, Diagnostic	Ophthalmic	Class 1	886.1380	2016-02-08
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-10-08

Official Correspondent

Alex Castillo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Corza Medical, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1835993	BARRON PRECISION INSTRUMENTS, L.L.C.	Grand Blanc, MI, US
3013602181	Blink Medical LTD	Solihull, GB
2242450	KATENA PRODUCTS, INC.	Randolph, NJ, US
1934420	KATENA PRODUCTS, INC.	Fenton, MO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852032	Visitec Co.	OCULAR PRESSURE REDUCER (MCCANNEL)	1985-08-12
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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 3015177648. Last updated year: 2026. Please use registration number 3015177648 when referencing this establishment in official correspondence.