Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011110913

FEI Number

3011110913

Entity Name

APPASAMY ASSOCIATES PRIVATE LIMITED (MN KUPPAM)

City/State/Country

Villupuram District Tamil Nadu, IN

Establishment Address

S.F.No. 144/1, Navammal Kapper Village,, M.N.Kuppam, Thennal Post, Kandamangalam Taluk,, Villupuram District Tamil Nadu 605102, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Appasamy Associates Private Limited (MN Kuppam) (Owner Number: 10048220)

Owner / Operator Contact Address

S.F.No. 144/1, Navammal Kapper Village,, M.N.Kuppam, Thennal Post, Kandamangalam Taluk, Villupuram District, IN-TN 605102, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Appasamy Retractor, Ophthalmic Appasamy Spud, Ophthalmic Appasamy Caliper, Ophthalmic Appasamy Expressor Appasamy CLamp, Eyelid, Ophthalmic Appasamy Hook, Ophthalmic Appasamy Probve, Trabeculotomy Appasamy Marker, Ocular Appasamy Depressor, Orbital Appasamy Punch, Corneo-Scleral Appasamy Introducer Sphere Appasamy Instrument, measuring , lens ac powered Appasamy Dilator, Lachrymal Appasamy Scissors, Ophthalmic Appasamy Clamp, Muscle, Ophthalmic Appasamy Cannula, Ophthalmic Appasamy Gauge, Lens, Ophthalmic Appasamy Curette, Ophthalmic Appasamy Microcsope Surgical Appasamy Microscope and Accessories Appasamy Cannula, Trocar, Ophthalmic Appasamy Forceps, Ophthalmic Appasamy, Ring, Ophthalmic (Flieringa) Appasamy Spoon, Ophthalmic Appasamy Spatula, Ophthalmic Appasamy PRobe, lachrymal Appasamy Trabeculatome Appasamy Knife, Ophthalmic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HNS	Expressor	Ophthalmic	Class 1	886.4350	2014-12-22
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2014-12-22
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2014-12-22
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2014-12-22
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2016-05-05
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2014-12-22
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	2016-05-05
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	2020-08-27
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2014-12-22
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2014-12-22
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2020-08-27
MTX	Microscope And Microscope Accessories, Reproduction, Assisted	Obstetrics/Gynecology	Class 1	884.6190	2020-08-27
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-05-05
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2014-12-22
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2014-12-22
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2016-05-05
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-12-22

Official Correspondent

Arvind Kasthuri

US Agent Details

Jayesh Patel Business: Amstermed Inc Email: info@amstermed.nl Phone: (714) 5954919

Related Public Records

Same Entity

Appasamy Associates Private Limited (MN Kuppam)

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
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

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-0308-2026	Alcon Research LLC	1	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011110913. Last updated year: 2026. Please use registration number 3011110913 when referencing this establishment in official correspondence.