Data / Medical devices / Singapore / SG Endoscopy Pte Ltd
SG Endoscopy Pte Ltd: FDA-registered device maker in Singapore North East, Singapore, 1 510(k) clearance
SG Endoscopy Pte Ltd is registered with the FDA (registration 3038613058) in Singapore North East, Singapore. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 2, 2025. Registered through 2027. 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
- 3038613058
- Address
- 77 Loyang Way, Singapore North East, Singapore, 508765
- Owner or operator
- SG Endoscopy Pte Ltd (10093585)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- June 6, 2025
- Registered through
- 2027
- Brand names listed
- Cleaning Brush, External, Cleaning Brush, Luer Port, Cleaning Brush, Working Channel, Ureteroscope, F88 Flexible Camera Control Unit (CCU), F88 Flexible Ureteroscope, Reverse Deflection, F88 Flexible Ureteroscope, Standard Deflection, Manual Leak Tester, Single Luer Stopcock (pack of 2) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 2, 2025 | K243894 | F88 URE-SD/RD Flexible Ureteroscope | FGB | Substantially Equivalent | Sg Endoscopy Pte, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 2, 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.