THD Disposable Anoscopes, Proctoscopes and Rectoscopes
FDA 510(k) K103647 · Thd Spa
510(k) numberK103647
Submission
- Device name
- THD Disposable Anoscopes, Proctoscopes and Rectoscopes
- Applicant
- Thd Spa
Imoa, IT - Received
- December 13, 2010
- Decision date
- March 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FER – Anoscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine and perform procedures within the anus and rectum.
Other 510(k)s with product code FER
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)FER · Traditional | Haemoband Surgical, Ltd. | 10/09/2025SE |
| K242668 | Gastro Concepts Air AssistFER · Traditional | Gastro Concepts, LLC | 12/13/2024SE |
| K230439 | WellCare AnoscopeFER · Traditional | Well Care (Wuhan) Medical Technology Co., Ltd. | 12/22/2023SE |
| K200021 | Applied Medical AnoscopeFER · Traditional | Applied Medical Resources | 01/06/2021SE |
| K171701 | GelPOINT Path Transanal Access PlatformFER · Traditional | Applied Medical Resources Corp. | 07/20/2017SE |
| K133393 | Gelpoint Path Transanal Access PlatformFER · Traditional | Applied Medical Resources Corp. | 01/02/2014SE |
| K133687 | THD N-Ano AnoscopeFER · Special | Thd Spa | 12/11/2013SE |
| K121604 | Anospec Disposable Ansoscope with LightFER · Traditional | Obp Corporation | 07/27/2012SE |
| K121135 | THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeFER · Traditional | Thd Spa | 06/01/2012SE |
| K110792 | Gelpoint PathFER · Traditional | Applied Medical Resources Corp. | 05/23/2011SE |
More from Applied Medical Resources Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K211623 | THD Procto Software SystemIYO · Special | 06/24/2021SE |
| K193512 | THD Procto Software SystemIYO · Traditional | 01/26/2020SE |
| K180135 | THD Anopress with THD SensyProbeKLA · Traditional | 03/08/2018SE |
| K161785 | THD AnopressKLA · Traditional | 03/14/2017SE |
| K141657 | THD RevolutionJAF · Traditional | 02/24/2015SE |
| K133687 | THD N-Ano AnoscopeFER · Special | 12/11/2013SE |
| K121135 | THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeFER · Traditional | 06/01/2012SE |
| K093497 | THD BandyFHN · Traditional | 07/15/2010SE |
| K091490 | Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesFER · Special | 06/11/2009SE |
| K090009 | THD Slide OneJAF · Special | 01/28/2009SE |
Questions and answers
When was THD Disposable Anoscopes, Proctoscopes and Rectoscopes cleared by the FDA?
THD Disposable Anoscopes, Proctoscopes and Rectoscopes (K103647) received a 510(k) decision of Substantially Equivalent on March 1, 2011, 78 days after the submission was received.
What is the product code of K103647?
The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.