Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617768

FEI Number

1000246164

Entity Name

KDANS SURGICAL PRIVATE LIMITED

City/State/Country

GANDHINAGAR Gujarat, IN

Establishment Address

G.I. D.C. INDUSTRIAL ESTATE, PLOT No. 701-703, SECTOR 28, GANDHINAGAR Gujarat 382028, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KDANS SURGICAL PRIVATE LIMITED (Owner Number: 9039272)

Owner / Operator Contact Address

G.I. D.C. INDUSTRIAL ESTATE, PLOT # 701-703, SECTOR 28, GANDHINAGAR, IN-NOTA 382028, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dilator, lachrymal Clip, iris retractor Caliper, ophthalmic Forceps, ophthalmic Set, lens, trial, ophthalmic Clamp, muscle, ophthalmic TRAY, SURGICAL, INSTRUMENT Trephine, manual, ophthalmic Cystotome Snare, enucleating Spatula, ophthalmic Knife, ophthalmic Marker, sclera Frame, trial, ophthalmic Cannula, ophthalmic Probe, lachrymal SCISSORS, OPHTHALMIC CHAIR, NEUROSURGICAL Depressor, orbital UNIT, SYRINGE, AIR AND/OR WATER Burr, corneal, manual Spud, ophthalmic Clamp, eyelid, ophthalmic Curette, ophthalmic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	1999-10-08
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	1999-10-08
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-08
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-08
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2000-09-07
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-08
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1999-10-08
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-06-11
HNY	Cystotome	Ophthalmic	Class 1	886.4350	1999-10-08
HNE	Snare, Enucleating	Ophthalmic	Class 1	886.4350	1999-10-08
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-09-07
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2025-04-15
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-08
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2000-09-07
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2000-09-07
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-08
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2007-03-23
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-08
HBN	Chair, Neurosurgical	Neurology	Class 1	882.4125	1999-10-08
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	1999-10-08
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	1999-10-08
HOF	Burr, Corneal, Manual	Ophthalmic	Class 1	886.4350	2007-03-23
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-08
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-08
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-08

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

KDANS SURGICAL PRIVATE LIMITED

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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
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-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.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617768. Last updated year: 2026. Please use registration number 9617768 when referencing this establishment in official correspondence.