FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
K Number: K020270
·
Decision Mar 14, 2002
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
25
Review Days
45
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Basic Information
- Device Name
- SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
- K Number
- K020270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sopro
- Date Received
- January 28, 2002
- Decision Date
- March 14, 2002
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
| K223470 | C50 | Dec 14, 2023 | Substantially Equivalent |
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| K103813 | SOPRO 281 | Mar 22, 2011 | Substantially Equivalent |
| K092329 | SOPIX 2 | Jul 20, 2010 | Substantially Equivalent |
| K092583 | SOPROLIFE | Jan 13, 2010 | Substantially Equivalent |
| K082796 | SOPRO 184 CAMERA | Apr 1, 2009 | Substantially Equivalent |
| K080122 | SOPRO 670 ARTHROSCOPIC PUMP | Jul 11, 2008 | Substantially Equivalent |
| K070783 | SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR | Dec 13, 2007 | Substantially Equivalent |
| K072912 | SOPRO 225 DUAL HALOGEN LIGHT SOURCE | Nov 16, 2007 | Substantially Equivalent |
| K070102 | SOPRO 162 CAMERA | Feb 20, 2007 | Substantially Equivalent |