Data / Medical devices / India / T.K. India Pvt. Ltd.
T.K. India Pvt. Ltd.: FDA-registered device maker in Chandigarh, India, 1 510(k) clearance
T.K. India Pvt. Ltd. is registered with the FDA (registration 3013515223) in Chandigarh, India. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 17, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013515223
- Address
- Plot No. Industrial Area Phase 2, Chandigarh, India, 160 002
- Owner or operator
- Teleflex (9062981)
- Roles
- Manufacturer
- First device listed
- March 3, 2005
- Registered through
- 2026
- Brand names listed
- DispoGrip, DispoLED, Dolphin, EquipLED, EquipLite, Fiber Optic Laryngoscope Blades and Handles, GreenLED, GreenSpec and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laryngoscope, Rigid | CCW | 1 | 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 |
|---|---|---|---|---|---|---|
| November 17, 2006 | K062523 | TRU-MR LARYNGOSCOPE SET | CCW | Substantially Equivalent | Truphatek International, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 17, 2006. 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.