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CADWELL INDUSTRIES INC

SIERRA SUMMIT · Gastroenterology and Urology

510(k): 1 Recall: 0 UDI: 16 MAUDE: 1 Class.: 10

510(k) Clearances (1)

Cadwell Sierra Summit, Cadwell Sierra Ascent

2017-03-01

Substantially Equivalent

UDI Registrations (16)

Sierra Summit

Sierra Summit 12 Ch. Amplifier

Sierra Summit/Ascent

Summit Tendon Hammer

Sierra Summit/Ascent

HDA280 Sennheiser Headphone

Sierra Summit

Sierra Summit StimTroller Plus

Sierra Summit

Summit Headphones Adapter

Sierra Summit

Ring or Bar Elect Switch Box, with DIN

Sierra Summit/Ascent

Sierra Summit VEP LED Goggles

Sierra Summit

VEP Cal Sensor

Sierra Summit

Sierra Summit Remote Input Box

Sierra Summit/Ascent

Sierra Summit Footswitch

Sierra Summit/Ascent

Summit 10 Ohn Shielded Headphones

Sierra Summit

Sierra Summit Base

Sierra Summit

Sierra Summit 2 Ch. Amplifier

Sierra Summit

Sierra Summit Bone Vibrator

Sierra Summit

RING/BAR ELECTRODE SWITCH BOX

Sierra Summit

SUMMIT ER-3C INSERT EARPHONE CABLE

MAUDE Adverse Events (1)

Malfunction

20221116

FDA Classification (10)

Device, Paste-On For Incontinence, Non-Sterile

Gastroenterology, Urology

String And Tubes, Gastrointestinal, To Locate Internal Bleeding

Gastroenterology, Urology

Plate, Patient

Gastroenterology, Urology

Dialyzer, Parallel Flow

Gastroenterology, Urology

Monitor, Esophageal Motility, Anorectal Motility, And Tube

Gastroenterology, Urology

Instrument, Biopsy, Mechanical, Gastrointestinal

Gastroenterology, Urology

Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs

Gastroenterology, Urology

Scoop

Gastroenterology, Urology

Hemodialyzer, Re-Use, High Flux

Gastroenterology, Urology

Cord, Electric, For Endoscope

Gastroenterology, Urology