Data / Medical devices / United States / Katena Products, Inc.
Katena Products, Inc.: FDA-registered device maker in Randolph, NJ, United States, 20 510(k) clearances
Katena Products, Inc. is registered with the FDA (registration 2242450) in Randolph, NJ, United States. It lists 70 device types. The FDA files 20 510(k) clearances under its listings, the newest dated October 13, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2242450
- Address
- 4 Middlebury Boulevard Unit #1, Randolph, NJ, United States, 07869
- Owner or operator
- Corza Medical, Inc. (2242450)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 8, 1977
- Registered through
- 2026
- Brand names listed
- AK Step Knife Double Footplate, Barron Donor Corneal Punches, Barron Radial Vacuum Trephines, Barron Vacuum Donor Punches, Blink, Castroviejo Lid Speculum, Clear Corneal Diamond Knife, Diamond Knife Crescent and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Ocular Pressure | LCC | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Burr, Corneal, Battery Powered, Rust Ring Removal | OHW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Burr, Corneal, Battery-Powered | HOG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Burr, Corneal, Manual | HOF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Caliper, Ophthalmic | HOE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Eyelid, Ophthalmic | HOD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Muscle, Ophthalmic | HOB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clip, Iris Retractor | HOC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Conformer, Ophthalmic | HQN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ophthalmic | HNZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cystotome | HNY | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Depressor, Orbital | HNX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Irrigation, Ocular Surgery | KYG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Lachrymal | HNW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Implant, Eye Sphere | HPZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Introducer, Sphere | HNP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lacrimal Stents And Intubation Sets | OKS | U | Specification developer | accessdata.fda.gov |
| Lens, Condensing, Diagnostic | HJL | 1 | Specification developer | accessdata.fda.gov |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | 2 | Specification developer | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Marker, Ocular | HMR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Marker, Sclera | HMQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Ophthalmic Suturing | HNM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pen, Marking, Surgical | HRP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Plug, Punctum | LZU | U | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prism, Gonioscopic | HKS | 1 | Specification developer | accessdata.fda.gov |
| Probe, Lachrymal | HNL | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe, Trabeculotomy | HNK | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Eyelid Spacer/Graft, Biologic | NXM | 2 | Specification developer | accessdata.fda.gov |
| Punch, Corneo-Scleral | HNJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur, Lachrymal Sac | HNG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Spoon, Ophthalmic | HNB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spud, Ophthalmic | HNA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Strip, Schirmer | KYD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Surgical Eye Tray | PZG | 1 | Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Weights, Eyelid, External | MML | 2 | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 13, 2015 | K152308 | Sensor Medical Single Use Tonometer Prism | HKY | Substantially Equivalent | Sensor Medical Technology, LLC | accessdata.fda.gov |
| December 16, 2014 | K142715 | Sensor Medical Family of Vitrectomy Lenses and Products | HJK | Substantially Equivalent | Sensor Medical Technology, LLC | accessdata.fda.gov |
| April 29, 2014 | K140368 | FAMILY OF DISPOSABLE LENSES | HKS | Substantially Equivalent | Sensor Medical Technology, LLC | accessdata.fda.gov |
| November 7, 2007 | K073010 | ROYALE AE 9036 LSP INJECTOR | MSS | Substantially Equivalent | Asico, LLC | accessdata.fda.gov |
| March 15, 2006 | K053622 | SURGISIS OCULAR GRAFT | NXM | Substantially Equivalent | Iop, Inc. | accessdata.fda.gov |
| July 14, 2003 | K023737 | INJECTOR | MSS | Substantially Equivalent | Anton Meyer & Co. , Ltd. | accessdata.fda.gov |
| April 25, 2003 | K030353 | MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS | OKS | Substantially Equivalent | Eagle Vision, Inc. | accessdata.fda.gov |
| July 26, 2002 | K020882 | SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG | LZU | Substantially Equivalent | Surgical Specialties Corp | accessdata.fda.gov |
| April 20, 1999 | K991130 | FLEXPLUG | LZU | Substantially Equivalent | Eagle Vision, Inc. | accessdata.fda.gov |
| April 12, 1999 | K990224 | LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET | MML | Substantially Equivalent | Labtician Ophthalmics, Inc. | accessdata.fda.gov |
| January 8, 1999 | K983607 | LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS | MML | Substantially Equivalent | Labtician Ophthalmics, Inc. | accessdata.fda.gov |
| May 8, 1995 | K945541 | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE | HKY | Substantially Equivalent | Rudolf Riester GmbH & Co. KG | accessdata.fda.gov |
| May 2, 1995 | K950520 | BURR, CORNEAL, BATTERY-POWERED | HOG | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
| May 23, 1994 | K942194 | QUANTUM BI-POLAR ELECTROSURGICAL CABLE | GEI | Substantially Equivalent | Quantum Instruments Corp. | accessdata.fda.gov |
| January 31, 1992 | K912576 | INSTRUMENT WIPE AND CORNEAL SHIELD | HOY | Substantially Equivalent | Katena Products, Inc. | accessdata.fda.gov |
| March 28, 1990 | K897190 | LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT | LZU | Substantially Equivalent | Look, Inc. | accessdata.fda.gov |
| February 15, 1990 | K897034 | K-SPONGE | HOZ | Substantially Equivalent | Katena Products, Inc. | accessdata.fda.gov |
| April 11, 1989 | K890920 | EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE | LZU | Substantially Equivalent | Eagle Vision, Inc. | accessdata.fda.gov |
| August 22, 1988 | K883233 | EV MONOCANALICULAR STENT (TM) | OKS | Substantially Equivalent | Eagle Vision, Inc. | accessdata.fda.gov |
| March 25, 1982 | K820526 | RELIEF VALVE-HONAN INTRAOC. PRESSURE | LCC | Substantially Equivalent | The Lebanon Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Weights, Eyelid, External
- All makers of Probe, Lachrymal
- All makers of Operating Room Accessories Table Tray
- All makers of Plug, Punctum
- All makers of Cannula, Ophthalmic
- All makers of Lacrimal Stents And Intubation Sets
Updated October 13, 2015. 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.