Data / Medical devices / United States / Suture Ease, Inc.
Suture Ease, Inc.: FDA-registered device maker in Galt, CA, United States, 1 510(k) clearance
Suture Ease, Inc. is registered with the FDA (registration 3009956343) in Galt, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 1, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009956343
- Address
- 908 C Street Suite F-1, Galt, CA, United States, 95632
- Owner or operator
- Suture Ease, Inc (10042219)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 1, 2012
- Registered through
- 2026
- Brand names listed
- CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor, CrossBow Reusable Passer, EZ Stitch, EZ Stitch Reusable Passer, LongBow Fascial Closure System, LongBow with Adaptor, Securus Fascial Closure System, SecurusEP Passer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Tissue Approximation Device | OCW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | 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 |
|---|---|---|---|---|---|---|
| December 1, 2017 | K172666 | CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor | OCW | Substantially Equivalent | Sutureease, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Ligature Passing And Knot Tying
- All makers of Endoscopic Tissue Approximation Device
Updated December 1, 2017. 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.