Data / Medical devices / India / Orion Sutures (india) Private Limited
Orion Sutures (india) Private Limited: FDA-registered device maker in BENGALURU Karnataka, India, 1 510(k) clearance
Orion Sutures (india) Private Limited is registered with the FDA (registration 3022766613) in BENGALURU Karnataka, India. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 21, 2003. 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
- 3022766613
- Address
- No. 138-B, "udayagiri Complex", 3RD Phase, Kiadb Industrial Area Peenya, BENGALURU Karnataka, India, 560058
- Owner or operator
- ORION SUTURES INDIA PRIVATE LIMITED (10085085)
- Roles
- Manufacturer
- First device listed
- May 5, 2022
- Registered through
- 2026
- Brand names listed
- NEUROSURGICAL SUTURE, Polyamide Synthetic Sutures
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Neurosurgical Suture | HAS | 1 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 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 |
|---|---|---|---|---|---|---|
| July 21, 2003 | K030177 | ORLON NONABSORABLE SURGICAL SUTURE USP | GAR | Substantially Equivalent | Sri Orion Pharmaceuticals & Sutures | accessdata.fda.gov |
Compare with other makers
Updated July 21, 2003. 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.