Cannula
FDA 510(k) K965121 · Origin Medsystems, Inc.
510(k) numberK965121
Submission
- Device name
- Cannula
- Applicant
- Origin Medsystems, Inc.
Menlo Park, CA, US - Received
- December 23, 1996
- Decision date
- March 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K992353 | Blunt Tip Trocar PortGCJ · Traditional | 07/30/1999SE |
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| K972685 | Origin Ligator DeviceGCJ · Traditional | 10/01/1997SE |
| K970611 | Origin Cardiac Stablizer OccluderDXC · Traditional | 08/19/1997SE |
| K964171 | Vasoview Balloon Dissection SystemGCJ · Traditional | 02/14/1997SE |
| K962104 | Airlift Balloon Retracton SystemGCJ · Traditional | 09/11/1996SE |
| K962005 | Extrahand Balloon RetractorGCJ · Traditional | 08/12/1996SE |
| K960936 | Resposable Trocar System [5MM, 5MM Short, 10MM and 12MM Sizes]HET · Traditional | 07/24/1996SE |
| K960637 | 5MM EndoscopeGCJ · Traditional | 06/14/1996SE |
| K955163 | Dissection ProbeGEI · Traditional | 01/24/1996SE |
Questions and answers
When was Cannula cleared by the FDA?
Cannula (K965121) received a 510(k) decision of Substantially Equivalent on March 20, 1997, 87 days after the submission was received.
What is the product code of K965121?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.