FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
THD N-ANO ANOSCOPE
K Number: K133687
·
Decision Dec 11, 2013
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
26
Applicant Total
13
Review Days
9
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Basic Information
- Device Name
- THD N-ANO ANOSCOPE
- K Number
- K133687
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thd Spa
- Date Received
- December 2, 2013
- Decision Date
- December 11, 2013
- Product Code
- FER
- 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 |
|---|---|---|---|
| FER | Anoscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Thd Spa
| K Number | Device Name | ||
|---|---|---|---|
| K211623 | THD Procto Software System | Jun 24, 2021 | Substantially Equivalent |
| K193512 | THD Procto Software System | Jan 26, 2020 | Substantially Equivalent |
| K180135 | THD Anopress with THD SensyProbe | Mar 8, 2018 | Substantially Equivalent |
| K161785 | THD ANOPRESS | Mar 14, 2017 | Substantially Equivalent |
| K141657 | THD REVOLUTION | Feb 24, 2015 | Substantially Equivalent |
| K121135 | THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE | Jun 1, 2012 | Substantially Equivalent |
| K103647 | THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES | Mar 1, 2011 | Substantially Equivalent |
| K093497 | THD BANDY | Jul 15, 2010 | Substantially Equivalent |
| K091490 | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES | Jun 11, 2009 | Substantially Equivalent |
| K090009 | THD SLIDE ONE | Jan 28, 2009 | Substantially Equivalent |