FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOPRO 281
K Number: K103813
·
Decision Mar 22, 2011
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
8
Applicant Total
25
Review Days
83
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Basic Information
- Device Name
- SOPRO 281
- K Number
- K103813
- 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
- December 29, 2010
- Decision Date
- March 22, 2011
- Product Code
- NTN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| NTN | Led Light Source | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Sopro
| K Number | Device Name | ||
|---|---|---|---|
| K223470 | C50 | Dec 14, 2023 | Substantially Equivalent |
| K121685 | SOPROCARE | Mar 12, 2013 | 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 |
| K031593 | SOPRO 61D | Sep 16, 2003 | Substantially Equivalent |