Data / Medical devices / Malaysia / SmartSurgN Sdn Bhd
SmartSurgN Sdn Bhd: FDA-registered device maker in Balakong Selangor, Malaysia, 2 510(k) clearances
SmartSurgN Sdn Bhd is registered with the FDA (registration 3026753388) in Balakong Selangor, Malaysia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3026753388
- Address
- No. 8, Jalan Alfa Impian 1 Taman Perindustrian Alfa Impian, Balakong Selangor, Malaysia, 43300
- Owner or operator
- SmartSurgN Incorporated (10077144)
- Roles
- Manufacturer
- First device listed
- December 13, 2022
- Registered through
- 2026
- Brand names listed
- AirSurgN, EyeRSurgN, IRLightSurgN, OptIcRSurgN, PrizMCurgN
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Confocal Optical Imaging | OWN | 2 | Manufacturer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | 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 |
|---|---|---|---|---|---|---|
| April 11, 2025 | K242772 | AirSurgN Insufflator (10030/AirSurgN) | HIF | Substantially Equivalent | SmartsurgN, Inc. | accessdata.fda.gov |
| November 29, 2022 | K213943 | SmartSurgN Visualization System | OWN | Substantially Equivalent | Smartsurgn Incorporated | accessdata.fda.gov |
Compare with other makers
Updated April 11, 2025. 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.