Data / Medical devices / United Kingdom / Sinclair Pharmaceuticals Ltd
Sinclair Pharmaceuticals Ltd: FDA-registered device maker in Chester Cheshire East, United Kingdom, 3 510(k) clearances
Sinclair Pharmaceuticals Ltd is registered with the FDA (registration 3011085362) in Chester Cheshire East, United Kingdom. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011085362
- Address
- Eden House, Lakeside Chester Business Park, Chester Cheshire East, United Kingdom, CH4 9QT
- Owner or operator
- Sinclair Pharma US, Inc. (10047999)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 25, 2016
- Registered through
- 2026
- Brand names listed
- Silhouette InstaLift, Silhouette Instalift
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Complaint file establishment, 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 |
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.