SmartSurgN Sdn Bhd

FDA Device Registration & Listing · Balakong Selangor, MY · Registration 3026753388

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3026753388
FEI Number
3026753388
Entity Name
SmartSurgN Sdn Bhd
City/State/Country
Balakong Selangor, MY
Establishment Address
No. 8, Jalan Alfa Impian 1, Taman Perindustrian Alfa Impian, Balakong Selangor 43300, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SmartSurgN Incorporated (Owner Number: 10077144)
Owner / Operator Contact Address
325 S 1st Street, Suite 120, San Jose, CA 95113, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242772
PMA Number
N/A

All Registered Proprietary Names

PrizMCurgN IRLightSurgN OptIcRSurgN EyeRSurgN AirSurgN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2022-12-13
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2025-04-18

Official Correspondent

No official correspondent registered.

US Agent Details

Jocelyn Long Business: SmartSurgN Inc Email: jocelyn.long@smartsurgn.com Phone: (408) 8028586

Related Public Records

Same Entity

SmartSurgN Incorporated
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
K260108 Stryker Endoscopy L12 LED Light Source with AIM 2026-02-12
K191144 Mauna Kea Technologies Cellvizio 100 Series System with Confocal Miniprobes 2020-01-24
K243591 Optosurgical, LLC OPTOVISION Endoscopic Light Source Unit 2025-02-19
K981334 Richard Wolf Medical Instruments Corp. LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) 1998-09-10

Similar Registrations

Registration Number Establishment Name Location
3010202439 Karl Storz Endoscopy-America, Inc. El Segundo, CA, US
3010177712 FIBERTECH CO., LTD. Sakura-shi Chiba, JP
3015612252 INTUITIVE SURGICAL, INC. Santa Clara, CA, US
3014342096 KARL STORZ SE & CO KG TUTTLINGEN Baden-Wurttemberg, DE
8010047 OLYMPUS MEDICAL SYSTEMS CORP. HACHIOJI-SHI Tokyo, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026753388. Last updated year: 2026. Please use registration number 3026753388 when referencing this establishment in official correspondence.
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