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510(k) K210478

Device
8mm Monopolar Curved Scissors
Applicant
Iconocare Health
510(k) number
K210478
Product code
QSM  
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-30
Date received
2021-02-19
Regulation
876.1500
Classification name
System, Surgical, Computer Controlled Instrument, Remanufactured
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rick Ferreira
Address
7825 E. Redfield Rd. Suite 103 Scottsdale AZ US 85260 85260

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QSM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)Restore Robotics2026-03-26
K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix2025-08-20
K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix2025-08-19
K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix2025-08-19
K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix2025-08-19
K2426108mm Monopolar Curved Scissors (470179)Iconocare Health2025-03-11
K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix2024-11-07

Legacy Summary#

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FDA Review#

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