Medical Device Manufacturer · US , Plymouth , MN

Stryker Ent - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2020

Recent clearances: SINUSPRIME Dilation System, TGS Guidewire and updated Scopis Software, TGS Universal Headrest with Mounting Arm

View 3 510(k) Devices ↓
3
Total
3
Cleared
0
Denied

FDA 510(k) Regulatory Record - Stryker Ent Ear, Nose, Throat ✕

3 devices
1-3 of 3
Cleared Oct 15, 2020
SINUSPRIME Dilation System
K201398 · LRC
Ear, Nose, Throat · 140d
Cleared Feb 21, 2020
TGS Guidewire and updated Scopis Software
K193118 · PGW
Ear, Nose, Throat · 101d
Cleared Feb 14, 2020
TGS Universal Headrest with Mounting Arm
K193502 · PGW
Ear, Nose, Throat · 58d
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