Company ยท FR
Sopro
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2023. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 13 |
| EIA | Unit, Operative Dental | 3 |
| NBL | Light-Induced Fluorescence Caries Detector | 3 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 |
| HIF | Insufflator, Laparoscopic | 1 |
| HRX | Arthroscope | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 |
| NTN | Led Light Source | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2023 | K223470 | C50 Sopro, FR | NBL |
| Mar 12, 2013 | K121685 | SOPROCARE Sopro | NBL |
| Mar 22, 2011 | K103813 | SOPRO 281 Sopro | NTN |
| Jul 20, 2010 | K092329 | SOPIX 2 Sopro | MUH |
| Jan 13, 2010 | K092583 | SOPROLIFE Sopro | NBL |
| Apr 1, 2009 | K082796 | SOPRO 184 CAMERA Sopro | GCJ |
| Jul 11, 2008 | K080122 | SOPRO 670 ARTHROSCOPIC PUMP Sopro | HRX |
| Dec 13, 2007 | K070783 | SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR Sopro | HIF |
| Nov 16, 2007 | K072912 | SOPRO 225 DUAL HALOGEN LIGHT SOURCE Sopro | GCJ |
| Feb 20, 2007 | K070102 | SOPRO 162 CAMERA Sopro | GCJ |
| Sep 16, 2003 | K031593 | SOPRO 61D Sopro, FR | GCJ |
| Jun 14, 2002 | K020915 | SOPRO LIGHT SOURCES AND ACCESSORIES Sopro, FR | GCJ |
| Mar 14, 2002 | K020270 | SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA Sopro, FR | GCJ |
| Dec 13, 2001 | K013090 | SOPRO 67D OPERATING ROOM CAMERA Sopro, FR | GCJ |
| Oct 5, 2001 | K012505 | SOPRO595 INTRA ORAL CAMERA Sopro, FR | EIA |
| Mar 31, 2000 | K000424 | S51D DIGITAL ENDOSCOPY CAMERA Sopro, FR | GCJ |
| Mar 31, 2000 | K000423 | S52D DIGITAL VIDEO LAPAROSCOPE Sopro, FR | GCJ |
| Mar 31, 2000 | K000422 | S57D DIGITAL OPERATING ROOM CAMERA Sopro, FR | GCJ |
| Apr 21, 1999 | K990948 | S575 INTRAORAL DOCKING DENTAL CAMERA Sopro, FR | EIA |
| Jan 11, 1999 | K983625 | S555 INTRAORAL DENTAL CAMERA Sopro, FR | EIA |
| Jan 2, 1998 | K973796 | S-41 &41S VIDEO IMAGING SYSTEM Sopro, FR | GCJ |
| Jan 2, 1998 | K973795 | S-52 ELECTRONIC VIDEO LAPAROSCOPE Sopro, FR | GCJ |
| Jan 2, 1998 | K973794 | S-57 VIDEO IMAGING SYSTEM Sopro, FR | GCJ |
| Dec 3, 1997 | K973798 | S-357 VIDEO IMAGING SYSTEM Sopro, FR | FET |
| Sep 18, 1997 | K972540 | S-357 VIDEO IMAGING SYSTEM Sopro, FR | FET |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||