Data / Medical devices / United States / Opus KSD, Inc.
Opus KSD, Inc.: FDA-registered device maker in East Pembroke, MA, United States, 1 510(k) clearance
Opus KSD, Inc. is registered with the FDA (registration 3011301103) in East Pembroke, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 9, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011301103
- Address
- 50 Corporate Park Drive Suite 710, East Pembroke, MA, United States, 02359
- Owner or operator
- Opus KSD, Inc. (10047949)
- Roles
- Manufacturer
- First device listed
- November 19, 2014
- Registered through
- 2026
- Brand names listed
- SubQ It! Bioabsorbable Skin Closure System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Staple, Implantable | GDW | 2 | Manufacturer | accessdata.fda.gov |
| Stapler, Skin | QQS | 1 | 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 |
|---|---|---|---|---|---|---|
| April 9, 2014 | K131563 | SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM | GDW | Substantially Equivalent | Opus Ksd, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 9, 2014. 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.