Data / Medical devices / India / Healthium Medtech Limited
Healthium Medtech Limited: FDA-registered device maker in SRI CITY Andhra Pradesh, India, 9 510(k) clearances
Healthium Medtech Limited is registered with the FDA (registration 3020983460) in SRI CITY Andhra Pradesh, India. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 9, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020983460
- Address
- PLOT NO.1605, Portia Road, Sri City, Tirupati District, SRI CITY Andhra Pradesh, India, 517 646
- Owner or operator
- HEALTHIUM MEDTECH LIMITED (9064005)
- Roles
- Manufacturer
- First device listed
- February 22, 2006
- Registered through
- 2026
- Brand names listed
- Black Braided Silk, Braided and Coated Polyester, Braided and Coated Polyglactin 910, Braided and Coated Polyglycolic acid, CARDIOPILENE, Dtek Mesh, Dtek Nylon, Dtek Poliglecaprone and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt | PTX | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 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 |
|---|---|---|---|---|---|---|
| June 9, 2008 | K081003 | TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | Sutures India Pvt., Ltd. | accessdata.fda.gov |
| June 9, 2008 | K081002 | MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE | GAM | Substantially Equivalent | Sutures India Pvt., Ltd. | accessdata.fda.gov |
| June 9, 2008 | K081001 | PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE | NEW | Substantially Equivalent | Sutures India Pvt., Ltd. | accessdata.fda.gov |
| July 26, 2006 | K060018 | TRULENE MESH | FTL | Substantially Equivalent | Sutures India Pvt., Ltd. | accessdata.fda.gov |
| June 3, 2005 | K041514 | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | GAP | Substantially Equivalent | Sutures India Private Limited | accessdata.fda.gov |
| June 3, 2005 | K041511 | TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE | GAW | Substantially Equivalent | Sutures India Private Limited | accessdata.fda.gov |
| June 2, 2005 | K041512 | NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE | GAT | Substantially Equivalent | Sutures India Private Limited | accessdata.fda.gov |
| June 2, 2005 | K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | GAR | Substantially Equivalent | Sutures India Private Limited | accessdata.fda.gov |
| April 8, 2005 | K041515 | TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE | GAM | Substantially Equivalent | Sutures India Private Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polypropylene
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Suture, Surgical, Absorbable, Polydioxanone
- All makers of Suture, Nonabsorbable, Silk
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
Updated June 9, 2008. 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.