GelPOINT Path Transanal Access Platform
FDA 510(k) K171701 · Applied Medical Resources Corp.
510(k) numberK171701
Submission
- Device name
- GelPOINT Path Transanal Access Platform
- Applicant
- Applied Medical Resources Corp.
Rancho Santa, CA, US - Received
- June 8, 2017
- Decision date
- July 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
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| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)FER · Traditional | Haemoband Surgical, Ltd. | 10/09/2025SE |
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| 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 |
| 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 |
| K103647 | THD Disposable Anoscopes, Proctoscopes and RectoscopesFER · Special | Thd Spa | 03/01/2011SE |
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Questions and answers
When was GelPOINT Path Transanal Access Platform cleared by the FDA?
GelPOINT Path Transanal Access Platform (K171701) received a 510(k) decision of Substantially Equivalent on July 20, 2017, 42 days after the submission was received.
What is the product code of K171701?
The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.