Data / Medical devices / United States / Sinclair Pharma Us, Inc.
Sinclair Pharma Us, Inc.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Sinclair Pharma Us, Inc. is registered with the FDA (registration 3007009755) in Irvine, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 27, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007009755
- Address
- 18 Technology Drive Suite 134, Irvine, CA, United States, 92618
- Owner or operator
- SINCLAIR PHARMA US, INC. (10032162)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- April 29, 2015
- Registered through
- 2026
- Brand names listed
- Silhouette Instalift, Silhouette Soft Suture, SMS 100 (2 x SMS 22-PL-3.1-NA + 1 x SMS 23-PL-3.1-NA), Silhouette Soft Suture, SMS 102 (3 x SMS 22-PL-3.1-NA), Silhouette Soft Suture, SMS 22 (5 x SMS 22-PL-3.1-NA), Silhouette Soft Suture, SMS 23 (5 x SMS 23-PL-3.1-NA), Silhouette Soft Suture, SMS 25 (5 x SMS 25-PL-3.1-NA), Silhouette Soft Suture, SMS 26 (5 x SMS 26-PL-3.1-NA)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 27, 2020 | K200140 | Silhouette Instalift | GAM | Substantially Equivalent | Silhouette Lift, Inc. | accessdata.fda.gov |
| June 16, 2017 | K163676 | Silhouette InstaLift | GAM | Substantially Equivalent | Silhouette Lift, Inc. | accessdata.fda.gov |
| April 24, 2015 | K142061 | SILHOUETTE INSTALIFT | GAM | Substantially Equivalent | Silhouette Lift, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 2, 2015 | 71615 | Class II | Terminated | Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position. | Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product. | accessdata.fda.gov |
Compare with other makers
Updated March 27, 2020. 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.