Data / Medical devices / India / Aurolab

Aurolab: FDA-registered device maker in MADURAI Tamil Nadu, India, 4 510(k) clearances

Name: Aurolab FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Aurolab is registered with the FDA (registration 9710098) in MADURAI Tamil Nadu, India. It lists 20 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 5, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9710098
FEI number: 3002957101
Address: No. 1, SIVAGANGAI MAIN ROAD VEERAPANJAN, MADURAI Tamil Nadu, India, 625020
Owner or operator: AUROLAB (9039871)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: October 18, 2007
Registered through: 2027
Brand names listed: AUROLAB NYLON SUTURES, AUROLAB SILK SUTURES, AuroChart, AuroTrocar, Auroblue, Aurodone, Aurolab Omniglo, Aurosil and more

Devices it lists

Device	Product code	Class	Role	Source
Aid, Surgical, Viscoelastic	LZP	3	Manufacturer	accessdata.fda.gov
Cannula, Trocar, Ophthalmic	NGY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Chart, Visual Acuity	HOX	1	Manufacturer	accessdata.fda.gov
Clip, Iris Retractor	HOC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Fluid, Intraocular	LWL	3	Contract manufacturer, Manufacturer	accessdata.fda.gov
Folders And Injectors, Intraocular Lens (Iol)	MSS	1	Contract manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Intraocular Lens	HQL	3	Contract manufacturer	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Light, Surgical, Ceiling Mounted	FSY	2	Repackager or relabeler	accessdata.fda.gov
Media, Corneal Storage	LYX	U	Manufacturer	accessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	1	Repackager or relabeler	accessdata.fda.gov
Needle, Ophthalmic Suturing	HNM	1	Manufacturer	accessdata.fda.gov
Refractometer, Ophthalmic	HKO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ring, Ophthalmic (Flieringa)	HNH	1	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Contract manufacturer	accessdata.fda.gov
Trypan Blue	LGY	1	Manufacturer	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 5, 2022	K221759	Cornisol	LYX	Substantially Equivalent	Aurolab	accessdata.fda.gov
September 15, 2014	K140039	POLYCRYL	GAM	Substantially Equivalent	Aurolab	accessdata.fda.gov
February 28, 2003	K024091	SILK SUTURES	GAP	Substantially Equivalent	Aurolab	accessdata.fda.gov
February 28, 2003	K024090	NYLON SUTURE	GAR	Substantially Equivalent	Aurolab	accessdata.fda.gov

Compare with other makers

Updated October 5, 2022. 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.