Data / Medical devices / United States / Konsyl Pharmaceuticals, Inc.
Konsyl Pharmaceuticals, Inc.: FDA-registered device maker in Easton, MD, United States, 2 510(k) clearances
Konsyl Pharmaceuticals, Inc. is registered with the FDA (registration 1119033) in Easton, MD, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 15, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1119033
- Address
- 29515 Canvasback Drive Suite B, Easton, MD, United States, 21601
- Owner or operator
- Konsyl Pharmaceuticals, Inc. (10027168)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 8, 2008
- Registered through
- 2026
- Brand names listed
- SITZMARKS, Sitzmarks
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Gastrointestinal Motility (Electrical) | FFX | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 15, 2018 | K181750 | SITZMARKS | FFX | Substantially Equivalent | Konsyl Pharmaceuticals | accessdata.fda.gov |
| July 8, 1988 | K881609 | SITZMARKS | FFX | Substantially Equivalent | Lafayette Pharmacal, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 15, 2018. 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.