FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
THD ANOPRESS
K Number: K161785
·
Decision Mar 14, 2017
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
30
Applicant Total
13
Review Days
258
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Basic Information
- Device Name
- THD ANOPRESS
- K Number
- K161785
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thd Spa
- Date Received
- June 29, 2016
- Decision Date
- March 14, 2017
- Product Code
- KLA
- 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 |
|---|---|---|---|
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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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 |
| K141657 | THD REVOLUTION | Feb 24, 2015 | Substantially Equivalent |
| K133687 | THD N-ANO ANOSCOPE | Dec 11, 2013 | 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 |