Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013576617

FEI Number

3013576617

Entity Name

APPASAMY ASSOCIATES PRIVATE LIMITED ( THRUVANDAR KOIL)

City/State/Country

Mannadipet Commune Puducherry, IN

Establishment Address

R. S. No: 112, Thiruvandarkoil Village,, Pondy - Villupuram main Road,, Mannadipet Commune Puducherry 605107, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Appasamy Associates Private Limited (Thiruvandar Koil) (Owner Number: 10052925)

Owner / Operator Contact Address

R. S. No: 112, Thiruvandarkoil Village,, Pondy - Villupuram main Road,, Mannadipet Commune,, IN-PY 605107, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Appasamy Depressor, Orbital Appasamy Forceps, Ophthalmic Appasamy Specula, Ophthalmic Appasamy Marker, Ocular Appa Auto lensometer Appasamy keratoscope - Ac powered Appasamy Expressor Appasamy Knife, Ophthalmic Appasamy Caliper, Ophthalmic Appasamy Probe, Trabeculotomy Appasamy Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal Appasamy Trabeculotome Appasamy Punch, corneo-scleral Appasamy Clamp, muscle, ophthalmic Appasamy Cannula, Ophthalmic Appa Chart Projector Appasamy Snare, Enucleating Appasamy Curette, Ophthalmic Appasamy Spud, Ophthalmic Appasamy Probe, Lachrymal Appasamy Chisel, Mastoid Appa I Chart Visual Acuity Appasamy Microscope, Surgical Appasamy Trephine, manual, ophthalmic Appasamy Microscope, Operating & Accessories, AC-Powered, Ophthalmic Appasamy Needle, Ophthalmic Suturing Appasamy Scissors, Ophthalmic Appasamy Clamp, Eyelid, Ophthalmic Appasamy Retractor, Ophthalmic Microscope and Microscope Accessories, Reproduction Assisted

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2020-08-27
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2020-08-27
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	2016-10-18
HLQ	Keratoscope, Ac-Powered	Ophthalmic	Class 1	886.1350	2020-08-27
HNS	Expressor	Ophthalmic	Class 1	886.4350	2020-08-27
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2020-08-27
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2020-08-27
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2020-08-27
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2020-08-27
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2016-10-18
HNE	Snare, Enucleating	Ophthalmic	Class 1	886.4350	2020-08-27
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2020-08-27
JYD	Chisel, Mastoid	General, Plastic Surgery	Class 1	878.4800	2020-08-27
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2016-10-18
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2016-10-18
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2016-10-18
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2020-08-27
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-08-27
MTX	Microscope And Microscope Accessories, Reproduction, Assisted	Obstetrics/Gynecology	Class 1	884.6190	2016-10-18

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 (Thiruvandar Koil)

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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8040381	INDO-GERMAN SURGICAL CORPORATION	Mumbai Maharashtra, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013576617. Last updated year: 2026. Please use registration number 3013576617 when referencing this establishment in official correspondence.