Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2242450

FEI Number

2242450

Entity Name

KATENA PRODUCTS, INC.

City/State/Country

Randolph, NJ, US

Establishment Address

4 Middlebury Boulevard, Unit #1, Randolph, NJ 07869, US

Establishment Type(s)

Repack or Relabel Medical Device,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

N/A

PMA Number

N/A

All Registered Proprietary Names

INSTRUMENT WIPES, PVA SPONGE INSTRUMENT TIP GUARDS Blink Eagle Flex; EaglePlug; Plug 1; SuperEagle; SuperFlex Diamond Knifes (multiple) Clear Corneal Diamond Knife Diamond Step Knife Diamond Knife Crescent AK Step Knife Double Footplate Tooke Corneal Knife Sharpoint Gulden Punctal Gauge Eagle Lacrimal Cannula Facial Infiltration Needle Peribulbar Needle Retrobulbar Needle Infant Speculum Temporal Speculum Castroviejo Lid Speculum multiple, needle holder names GRAETHER Honan Balloon FLIERINGA FIXATION RING MCNEILL GLOBAL FIXATION RING SURG-I-BAND; INSTR. MARKING TAPE LID LOAD Ophthalmic Burr Wright Fascia Needle DuraPlug Barron Donor Corneal Punches Barron Vacuum Donor Punches Barron Radial Vacuum Trephines Katena Trephine Blades KATENA DISPOSABLES EaglePlug TearFlow; Flow Controller MALLET STAINLESS STEEL GASS SCLERAL MARKER tarSys

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-10-08
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2016-11-10
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2016-11-10
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-10-31
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Ophthalmic	Class 2	886.1385	2016-02-08
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-10-08
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2016-11-14
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2007-11-02
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1993-01-01
HNG	Rongeur, Lachrymal Sac	Ophthalmic	Class 1	886.4350	2001-08-29
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1993-01-01
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-06-24
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HJL	Lens, Condensing, Diagnostic	Ophthalmic	Class 1	886.1380	2016-02-08
HKS	Prism, Gonioscopic	Ophthalmic	Class 1	886.1660	2016-02-08
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Ophthalmic	Class 1	886.4070	2013-06-10
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
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2007-10-08
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-08-29
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2021-07-29
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2013-01-23
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
LCC	Applicator, Ocular Pressure	Ophthalmic	Class 2	886.4610	2008-03-14
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1993-01-01
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2001-08-29
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	1993-01-01
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2009-06-11
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2016-11-14
HOG	Burr, Corneal, Battery-Powered	Ophthalmic	Class 1	886.4070	2007-10-08
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-08-21
HJL	Lens, Condensing, Diagnostic	Ophthalmic	Class 1	886.1380	2016-02-08
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2022-04-12
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-08-29
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2021-07-29
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	1993-01-01
HNJ	Punch, Corneo-Scleral	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
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2007-10-31
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-10-08
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2007-10-31
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1993-01-01
PZG	Surgical Eye Tray	Ophthalmic	Class 1	886.4350	2019-08-28
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	1977-12-08
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-10-08
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1993-01-01
KYD	Strip, Schirmer	Ophthalmic	Class 1	886.1800	2016-11-10
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	1993-01-01
NXM	Prosthesis, Eyelid Spacer/Graft, Biologic	Ophthalmic	Class 2	886.3130	2016-09-19
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1993-01-01
HOF	Burr, Corneal, Manual	Ophthalmic	Class 1	886.4350	1977-12-08

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
1934420	KATENA PRODUCTS, INC.	Fenton, MO, US
3015177648	KATENA PRODUCTS, INC.	Parsippany, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
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

Similar Registrations

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2029275	Sterigenics U.S., LLC	Corona, CA, US
9615745	FCI SAS	BESANCON Doubs, FR
3015177648	KATENA PRODUCTS, INC.	Parsippany, NJ, US
3031056804	Symatese	Vourles Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2242450. Last updated year: 2026. Please use registration number 2242450 when referencing this establishment in official correspondence.