Data / Medical devices / United States / Sharp Fluidics, Inc.
Sharp Fluidics, Inc.: FDA-registered device maker in El Granada, CA, United States, 3 510(k) clearances
Sharp Fluidics, Inc. is registered with the FDA (registration 3013002341) in El Granada, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013002341
- Address
- 298 Carmel Ave, El Granada, CA, United States, 94018
- Owner or operator
- Sharp Fluidics, Inc (10052447)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 5, 2020
- Registered through
- 2026
- Brand names listed
- PDS Anchor, neoClose - NCAAX4-U, (Drivers) NCAGXL-U , NCAAX2-U, NCAGR-U, NCAGRX2-U, NCAG-U (A nchor/Guard)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | 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 8, 2018 | K173917 | neoClose PDS | GCJ | Substantially Equivalent | Neosurgical, Ltd. | accessdata.fda.gov |
| November 12, 2014 | K142903 | neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US | GCJ | Substantially Equivalent | Neosurgical, Ltd. | accessdata.fda.gov |
| July 18, 2013 | K131688 | NEOCLOSE HASSON, NEOCLOSE UNIVERSAL | GCJ | Substantially Equivalent | Neosurgical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Staple, Implantable
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
Updated November 8, 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.