Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040382

FEI Number

6750

Entity Name

PAUL INSTRUMENTS (INDIA)

City/State/Country

CALCUTTA West Bengal, IN

Establishment Address

11/2 TAMER LN., CALCUTTA West Bengal --, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PAUL INSTRUMENTS (INDIA) (Owner Number: 8040382)

Owner / Operator Contact Address

2500 Sandersville Road, --, Lexington, KY 40511, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stephens Trial Lens Frame/Case Stephens Lens Maddox Stephens Corneoscleral Punch Stephens Rongeur Stephens Cannula Stephens Muscle Hook, Stephens Clamp, Stephen Muscle Clamp Probe Stephens Dilator Ophthalmic Ring Stephens Cystotome Stephens Probe, Stephens Trabulectomy Probe Stephens Currette Stephens Artificial Eye clip, Retractor Needle Holder Stephens Spud Measuring Instrument Stephens Manual Corneal Burr Clamp Stephens Spatula Corneal measuring instrument Caliper Ophthalmic Spoon Ocular Marker Snare Stephens Orbital Depressor, Stephens Depressor Stephens Trial Frame Tray Stephens Expressor Stephens Scissors Stephens Instruments Ophthalmic Instrument Stand Specula Stephens Eye Shield Stephens Ruler, Stephens Punctometer Erisophake

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	1985-12-06
HKR	Lens, Maddox	Ophthalmic	Class 1	886.1400	1985-12-06
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	1985-12-06
HNG	Rongeur, Lachrymal Sac	Ophthalmic	Class 1	886.4350	1985-12-06
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-06
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-06
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1985-12-06
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	1985-12-06
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	1985-12-06
HNY	Cystotome	Ophthalmic	Class 1	886.4350	1985-12-06
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	1985-12-06
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-06
HQH	Eye, Artificial, Non-Custom	Ophthalmic	Class 1	886.3200	1985-12-06
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	1985-12-06
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1989-10-18
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-06
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	1985-12-06
HOF	Burr, Corneal, Manual	Ophthalmic	Class 1	886.4350	1985-12-06
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-06
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-06
HJB	Instrument, Measuring, Corneal Radius	Ophthalmic	Class 1	886.1450	1985-12-06
HQW	Clip, Tantalum, Ophthalmic	Ophthalmic	Class 2	886.3100	1985-12-06
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-10
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-06
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	1985-12-06
HNE	Snare, Enucleating	Ophthalmic	Class 1	886.4350	1985-12-06
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	1985-12-06
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	1985-12-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1989-10-18
HNS	Expressor	Ophthalmic	Class 1	886.4350	1985-12-06
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-06
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	1985-12-06
HMG	Stand, Instrument, Ophthalmic, Non-Powered	Ophthalmic	Class 1	886.1860	1985-12-06
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	1985-12-06
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	1985-12-06
HLE	Ruler, Nearpoint (Punctometer)	Ophthalmic	Class 1	886.1790	1985-12-06
HNT	Erisophake	Ophthalmic	Class 1	886.4350	1985-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

Archna Johnson Email: regulatory@usiol.com Phone: (859) 2594925

Related Public Records

Same Entity

PAUL INSTRUMENTS (INDIA)

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
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21
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-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-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

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3001762432	IKETANI Co., Ltd.	Kiso-gun, Nagano-KEN, JP
3003039352	EPSILON EYE CARE PVT., LTD.	MUMBAI Maharashtra, IN
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN
3003951061	M/S TARUN ENTERPRISES	Prayagraj, Uttar Pradesh, IN
5470	H. OGINO & CO., LTD.	Yokohama Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040382. Last updated year: 2026. Please use registration number 8040382 when referencing this establishment in official correspondence.