Medical Device Manufacturer · FR , Marseille

Sopro - FDA 510(k) Cleared Devices

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

Sopro, specialized in surgical visualization and imaging devices for general and plastic surgery applications. The company operated a manufacturing facility in Marseille, France.

Sopro received 25 FDA 510(k) clearances from 25 total submissions between 1997 and 2023. The company focused exclusively on General & Plastic Surgery devices, particularly endoscopy cameras, digital operating room cameras, and light source systems. All submissions resulted in clearance with no denials on record.

The company's product portfolio included digital endoscopy cameras, laparoscopes, operating room cameras, and halogen light sources. These devices supported minimally invasive surgical visualization across multiple surgical specialties.

Sopro has been inactive since 2023 with no recent FDA 510(k) submissions. This profile reflects the company's historical regulatory record. Explore the complete list of cleared device names, product codes, and clearance dates in the database.

FDA 510(k) Regulatory Record - Sopro
25 devices
1-25 of 25
Cleared Dec 14, 2023
C50
K223470 · NBL
Dental · 392d
Cleared Mar 12, 2013
SOPROCARE
K121685 · NBL
Dental · 278d
Cleared Mar 22, 2011
SOPRO 281
K103813 · NTN
Gastroenterology & Urology · 83d
Cleared Jul 20, 2010
SOPIX 2
K092329 · MUH
Radiology · 350d
Cleared Jan 13, 2010
SOPROLIFE
K092583 · NBL
Dental · 145d
Cleared Apr 01, 2009
SOPRO 184 CAMERA
K082796 · GCJ
General & Plastic Surgery · 190d
Cleared Jul 11, 2008
SOPRO 670 ARTHROSCOPIC PUMP
K080122 · HRX
Orthopedic · 176d
Cleared Dec 13, 2007
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
K070783 · HIF
Obstetrics & Gynecology · 267d
Cleared Nov 16, 2007
SOPRO 225 DUAL HALOGEN LIGHT SOURCE
K072912 · GCJ
General & Plastic Surgery · 35d
Cleared Feb 20, 2007
SOPRO 162 CAMERA
K070102 · GCJ
General & Plastic Surgery · 41d
Cleared Sep 16, 2003
SOPRO 61D
K031593 · GCJ
General & Plastic Surgery · 118d
Cleared Jun 14, 2002
SOPRO LIGHT SOURCES AND ACCESSORIES
K020915 · GCJ
General & Plastic Surgery · 85d
Cleared Mar 14, 2002
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
K020270 · GCJ
General & Plastic Surgery · 45d
Cleared Dec 13, 2001
SOPRO 67D OPERATING ROOM CAMERA
K013090 · GCJ
General & Plastic Surgery · 87d
Cleared Oct 05, 2001
SOPRO595 INTRA ORAL CAMERA
K012505 · EIA
Dental · 63d
Cleared Mar 31, 2000
S57D DIGITAL OPERATING ROOM CAMERA
K000422 · GCJ
General & Plastic Surgery · 51d
Cleared Mar 31, 2000
S52D DIGITAL VIDEO LAPAROSCOPE
K000423 · GCJ
General & Plastic Surgery · 51d
Cleared Mar 31, 2000
S51D DIGITAL ENDOSCOPY CAMERA
K000424 · GCJ
General & Plastic Surgery · 51d
Cleared Apr 21, 1999
S575 INTRAORAL DOCKING DENTAL CAMERA
K990948 · EIA
Dental · 30d
Cleared Jan 11, 1999
S555 INTRAORAL DENTAL CAMERA
K983625 · EIA
Dental · 88d
Cleared Jan 02, 1998
S-57 VIDEO IMAGING SYSTEM
K973794 · GCJ
General & Plastic Surgery · 88d
Cleared Jan 02, 1998
S-52 ELECTRONIC VIDEO LAPAROSCOPE
K973795 · GCJ
General & Plastic Surgery · 88d
Cleared Jan 02, 1998
S-41 &41S VIDEO IMAGING SYSTEM
K973796 · GCJ
General & Plastic Surgery · 88d
Cleared Dec 03, 1997
S-357 VIDEO IMAGING SYSTEM
K973798 · FET
Gastroenterology & Urology · 58d
Cleared Sep 18, 1997
S-357 VIDEO IMAGING SYSTEM
K972540 · FET
Gastroenterology & Urology · 73d
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