Data / Medical devices / United States / Implicitcare, LLC
Implicitcare, LLC: FDA-registered device maker in Newport Beach, CA, United States, 1 510(k) clearance
Implicitcare, LLC is registered with the FDA (registration 3008142750) in Newport Beach, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 13, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008142750
- Address
- 20241 Sw Birch St Ste 201, Newport Beach, CA, United States, 92660
- Owner or operator
- ImplicitCare, LLC (10030916)
- Roles
- Manufacturer
- First device listed
- November 30, 2009
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | 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 |
|---|---|---|---|---|---|---|
| November 13, 2009 | K091061 | IMPLICITGUIDE SURGICAL SUTURE SYSTEM | GAT | Substantially Equivalent | Implicitcare, LLC | accessdata.fda.gov |
Compare with other makers
Updated November 13, 2009. 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.