Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017970077

FEI Number

3017970077

Entity Name

KALSON SURGICAL

City/State/Country

Sialkot Punjab, PK

Establishment Address

M.N Kalson 122 - Bullowal, Kotli Loharan West, Sialkot Punjab 51220, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kalson Surgical (Owner Number: 10079685)

Owner / Operator Contact Address

M.N Kalson 122 - Bullowal, Kotli Loharan West, Sialkot, PK-PB 51220, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Specula, Ophthalmic Clamp, eyelid, ophthalmic Sinksey Hook, Angled Corneal Scissors Tenotomy Scissors Iris Scissors Enucleation Scissors Caliper, Ophthalmic Sinksey Hook, Angled Gauge, lens Cannula, Ophthalmic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2021-01-18
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2021-01-18
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-12-18
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-12-18
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2021-01-18
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-12-18
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2021-01-18
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2021-01-18

Official Correspondent

Teresa Burton

US Agent Details

Archna Johnson Business: Krishna Imports, Inc. DBA Stephens Instruments Email: kris.burchett@usiol.com Phone: (859) 2594925

Related Public Records

Same Entity

Kalson Surgical

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
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.

Similar Registrations

Registration Number	Establishment Name	Location
3006677911	Crestpoint Management Ltd.	Crestwood, MO, US
3003644849	DR. FRIGZ INTERNATIONAL (PVT) LTD.	SIALKOT, Punjab, PK
3030451558	BIS MASTERMED	Kosice Kosicky, SK
3006059835	SURGIKARE	SIALKOT Punjab, PK
9616250	ASANUS MEDIZINTECHNIK GMBH	NEUHAUSEN OBECK Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017970077. Last updated year: 2026. Please use registration number 3017970077 when referencing this establishment in official correspondence.