Data / Medical devices / United States / Stryker Endoscopy
Stryker Endoscopy: FDA-registered device maker in Greenwood Village, CO, United States, 7 510(k) clearances
Stryker Endoscopy is registered with the FDA (registration 3012103978) in Greenwood Village, CO, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 20, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012103978
- Address
- 5670 Greenwood Plaza Blvd Suite 125, Greenwood Village, CO, United States, 80111
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Specification developer
- First device listed
- May 19, 1995
- Registered through
- 2027
- Brand names listed
- Big Dog Suture Center, Crosscut, ICONIX SPEED, ICONIX Self Punching Anchor, ICONIX TT, ICONIX w/ Needles, ProCinch, ProCinch Reverse Tension Adjustable Loop and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cutter, Wire | HXZ | 1 | Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 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 20, 2017 | K172921 | Stryker Self-Punching ICONIX | MBI | Substantially Equivalent | Stryker | accessdata.fda.gov |
| August 24, 2017 | K171465 | Stryker Self-Punching ICONIX | MBI | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 31, 2017 | K170098 | ICONIX TT All Suture Anchor | MBI | Substantially Equivalent | Stryker | accessdata.fda.gov |
| November 10, 2016 | K162310 | XBraid TT Suture Tape | GAT | Substantially Equivalent | Stryker | accessdata.fda.gov |
| August 13, 2015 | K150584 | Stryker Suture Tape | GAT | Substantially Equivalent | Stryker | accessdata.fda.gov |
| June 29, 2015 | K151201 | Stryker ICONIX with Needles | MBI | Substantially Equivalent | Stryker | accessdata.fda.gov |
| April 17, 2015 | K150416 | ProCinch Adjustable Loop Device | HTY | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Cutter, Wire
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Pin, Fixation, Smooth
Updated November 20, 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.