FDA Registration Active 🇺🇸 United States

11cm iQ Knife

Reg #: 3015967359 · FEI: 3015967359 · Expires 2025
Products
1
Proprietary Names
17
Establishment Types
2
Classifications
1

Registration Details

Registration Name
Stryker Instruments
Registration Number
3015967359
FEI Number
3015967359
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
1941 Stryker Way
City
Portage
State
MI
ZIP
49002
Country
US

Regulatory Submissions

510(k) Number
K213824

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
Instrument, Ultrasonic Surgical LFL

Proprietary Names

11cm iQ Knife 18cm iQ Apex Micro Claw 12cm iQ Large 11cm iQ Apex Knife 20cm iQ Apex 360 10cm iQ Broad Knife 18cm iQ Micro Claw 12cm iQ Apex 360 SONOPET IQ CONSOLE 12cm iQ Barracuda 12cm iQ Standard 12cm iQ Serrated Large 20cm iQ Standard 12cm iQ Claw 12cm iQ Micro Claw 12cm iQ Micro 12cm iQ 120 Claw

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198