Hemorpex System
FDA 510(k) K090432 · Angiologica B. M. Srl
510(k) numberK090432
Submission
- Device name
- Hemorpex System
- Applicant
- Angiologica B. M. Srl
San Martino Siccomario, Pavia, IT - Received
- February 19, 2009
- Decision date
- May 29, 2009
- 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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| K133687 | THD N-Ano AnoscopeFER · Special | Thd Spa | 12/11/2013SE |
| K121604 | Anospec Disposable Ansoscope with LightFER · Traditional | Obp Corporation | 07/27/2012SE |
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| K110792 | Gelpoint PathFER · Traditional | Applied Medical Resources Corp. | 05/23/2011SE |
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Questions and answers
When was Hemorpex System cleared by the FDA?
Hemorpex System (K090432) received a 510(k) decision of Substantially Equivalent on May 29, 2009, 99 days after the submission was received.
What is the product code of K090432?
The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.