Gelpoint Path
FDA 510(k) K110792 · Applied Medical Resources Corp.
510(k) numberK110792
Submission
- Device name
- Gelpoint Path
- Applicant
- Applied Medical Resources Corp.
Rancho Santa, CA, US - Received
- March 21, 2011
- Decision date
- May 23, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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| K121604 | Anospec Disposable Ansoscope with LightFER · Traditional | Obp Corporation | 07/27/2012SE |
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Questions and answers
When was Gelpoint Path cleared by the FDA?
Gelpoint Path (K110792) received a 510(k) decision of Substantially Equivalent on May 23, 2011, 63 days after the submission was received.
What is the product code of K110792?
The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.