Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview Anoscope
FDA 510(k) K060623 · Cook Ireland, Ltd.
510(k) numberK060623
Submission
- Device name
- Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview Anoscope
- Applicant
- Cook Ireland, Ltd.
Limerick, IE - Received
- March 8, 2006
- Decision date
- September 6, 2006
- 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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Questions and answers
When was Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview Anoscope cleared by the FDA?
Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview Anoscope (K060623) received a 510(k) decision of Substantially Equivalent on September 6, 2006, 182 days after the submission was received.
What is the product code of K060623?
The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.