FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
THD BANDY
K Number: K093497
·
Decision Jul 15, 2010
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
21
Applicant Total
13
Review Days
245
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THD BANDY
- K Number
- K093497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thd Spa
- Date Received
- November 12, 2009
- Decision Date
- July 15, 2010
- Product Code
- FHN
- 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 |
|---|---|---|---|
| FHN | Ligator, Hemorrhoidal | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FHN), ordered by most recent decision date.
Multi-Band Ligator
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ligation Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Wi-3 HAL-RAR System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEXUS HEMORRHOID LIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HAEMOBAND MULTI-LIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| 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 |
| K091490 | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES | Jun 11, 2009 | Substantially Equivalent |
| K090009 | THD SLIDE ONE | Jan 28, 2009 | Substantially Equivalent |