Medical Device Manufacturer · FR , Marseille

Sopro

25 submissions · 25 cleared · Since 1997
25
Total
25
Cleared
0
Denied

Sopro — FDA 510(k) Submissions

Sopro has submitted 25 FDA 510(k) premarket notifications since 1997, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Laparoscope, General & Plastic Surgery, Unit, Operative Dental, Laser, Fluorescence Caries Detection, Endoscopic Video Imaging System/component, Gastroenterology-urology, Insufflator, Laparoscopic . Use the specialty filter in the sidebar to narrow results.

25 devices
1–25 of 25
C50
K223470 · NBL Laser, Fluorescence... · Dental
Dec 2023 392d
SOPROCARE
K121685 · NBL Laser, Fluorescence... · Dental
Mar 2013 278d
SOPRO 281
K103813 · NTN Led Light Source · Gastroenterology & Urology
Mar 2011 83d
SOPIX 2
K092329 · MUH System, X-ray, Extraoral... · Radiology
Jul 2010 350d
SOPROLIFE
K092583 · NBL Laser, Fluorescence... · Dental
Jan 2010 145d
SOPRO 184 CAMERA
K082796 · GCJ Laparoscope, General &... · General & Plastic Surgery
Apr 2009 190d
SOPRO 670 ARTHROSCOPIC PUMP
K080122 · HRX Arthroscope · Orthopedic
Jul 2008 176d
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
K070783 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Dec 2007 267d
SOPRO 225 DUAL HALOGEN LIGHT SOURCE
K072912 · GCJ Laparoscope, General &... · General & Plastic Surgery
Nov 2007 35d
SOPRO 162 CAMERA
K070102 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 2007 41d
SOPRO 61D
K031593 · GCJ Laparoscope, General &... · General & Plastic Surgery
Sep 2003 118d
SOPRO LIGHT SOURCES AND ACCESSORIES
K020915 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jun 2002 85d
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
K020270 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 2002 45d
SOPRO 67D OPERATING ROOM CAMERA
K013090 · GCJ Laparoscope, General &... · General & Plastic Surgery
Dec 2001 87d
SOPRO595 INTRA ORAL CAMERA
K012505 · EIA Unit, Operative Dental · Dental
Oct 2001 63d
S57D DIGITAL OPERATING ROOM CAMERA
K000422 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 2000 51d
S52D DIGITAL VIDEO LAPAROSCOPE
K000423 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 2000 51d
S51D DIGITAL ENDOSCOPY CAMERA
K000424 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 2000 51d
S575 INTRAORAL DOCKING DENTAL CAMERA
K990948 · EIA Unit, Operative Dental · Dental
Apr 1999 30d
S555 INTRAORAL DENTAL CAMERA
K983625 · EIA Unit, Operative Dental · Dental
Jan 1999 88d
S-57 VIDEO IMAGING SYSTEM
K973794 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jan 1998 88d
S-52 ELECTRONIC VIDEO LAPAROSCOPE
K973795 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jan 1998 88d
S-41 &41S VIDEO IMAGING SYSTEM
K973796 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jan 1998 88d
S-357 VIDEO IMAGING SYSTEM
K973798 · FET Endoscopic Video Imaging... · Gastroenterology & Urology
Dec 1997 58d
S-357 VIDEO IMAGING SYSTEM
K972540 · FET Endoscopic Video Imaging... · Gastroenterology & Urology
Sep 1997 73d
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