FDA Registration
Active
🇺🇸 United States
Stryker Endoscopy
Reg #: 3012103978
·
FEI: 3012103978
·
Expires 2026
Products
4
Proprietary Names
12
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Stryker Endoscopy
- Registration Number
- 3012103978
- FEI Number
- 3012103978
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5670 Greenwood Plaza Blvd, Suite 125
- City
- Greenwood Village
- State
- CO
- ZIP
- 80111
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171465
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2017-09-28 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1995-05-19 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2015-08-06 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2015-08-13 |
Proprietary Names
ICONIX SPEED
SharpShooter Handle
ICONIX Self Punching Anchor
Crosscut
WIRE CUTTER
Big Dog Suture Center
ProCinch
ProCinch Standard Tension Adjustable Loop
ProCinch Reverse Tension Adjustable Loop
ICONIX TT
XBraid TT
ICONIX w/ Needles
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility