Data / Medical devices / United States / SRI Healthcare, LLC
SRI Healthcare, LLC: FDA-registered device maker in Mebane, NC, United States, 12 510(k) clearances
SRI Healthcare, LLC is registered with the FDA (registration 1055892) in Mebane, NC, United States. It lists 9 device types. The FDA files 12 510(k) clearances under its listings, the newest dated January 14, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1055892
- FEI number
- 1000111202
- Address
- 1416 Dogwood Way, Mebane, NC, United States, 27302
- Owner or operator
- SRI Healthcare, LLC (10054706)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 17, 2017
- Registered through
- 2026
- Brand names listed
- Novo Health Services, SRI Healthcare, SRI Healthcare, LLC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Basin, Emesis | FNY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Adhesive, Aerosol | KGT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Repackager or relabeler | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | 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 |
|---|---|---|---|---|---|---|
| January 14, 2011 | K102864 | 84E SERIES SINGLE PLY WRAPPER | FRG | Substantially Equivalent | Lac Mac, Ltd. | accessdata.fda.gov |
| December 17, 2009 | K092344 | LAC-MAC INNERBLOC LR SURGICAL GOWNS | FYA | Substantially Equivalent | Lac Mac, Ltd. | accessdata.fda.gov |
| May 29, 2009 | K090383 | SRI LEVEL II SURGICAL GOWN | FYA | Substantially Equivalent | Sri Surgical | accessdata.fda.gov |
| November 17, 2008 | K080796 | SRI LP DRAPE | KKX | Substantially Equivalent | Sri/Surgical Express | accessdata.fda.gov |
| November 13, 2008 | K080723 | SRI LP GOWN | FYA | Substantially Equivalent | Sri/Surgical Express, Inc. | accessdata.fda.gov |
| November 13, 2008 | K080707 | SRI PLR GOWN | FYA | Substantially Equivalent | Sri/Surgical Express | accessdata.fda.gov |
| August 9, 2006 | K061491 | LAC-MAC INNERBLOC O.R. GOWN | FYA | Substantially Equivalent | Lac Mac, Ltd. | accessdata.fda.gov |
| March 16, 2005 | K041541 | COMPEL MLR SURGICAL GOWNS | FYA | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| September 16, 2003 | K031933 | MEDLINE REUSABLE SURGICAL GOWNS (100X) | FYA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| May 30, 2003 | K031362 | LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS | KKX | Substantially Equivalent | Lac Mac, Ltd. | accessdata.fda.gov |
| February 16, 2001 | K003755 | MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES | FYA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| December 14, 1998 | K982694 | MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES | FYA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Surgical, Antimicrobial
- All makers of Gown, Surgical
- All makers of Fiber, Medical, Absorbent
- All makers of Drape, Adhesive, Aerosol
- All makers of Wrap, Sterilization
- All makers of Basin, Emesis
Updated January 14, 2011. 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.