Origin Secondary Cannula and Trocar
FDA 510(k) K922460 · Origin Medsystems, Inc.
510(k) numberK922460
Submission
- Device name
- Origin Secondary Cannula and Trocar
- Applicant
- Origin Medsystems, Inc.
San Carlos, CA, US - Received
- May 26, 1992
- Decision date
- September 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEA – Cannula, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003965 | MRI Safe InstrumentsGEA · Traditional | Aesculap, Inc. | 03/16/2001SE |
| K982472 | Genicon TrocarGEA · Traditional | Genicon, LC | 02/04/1999SE |
| K954599 | Conmed Trogard Electronic Trocar SystemGEA · Traditional | Conmedcorp | 11/27/1995SE |
| K920110 | Endopath Disposable Thoracic Trocar SleeveGEA · Traditional | ETHICON, Inc. | 04/02/1992SE |
| K911262 | Disposable Specimen Bag W/Cannula and IntroducerGEA · Traditional | ETHICON, Inc. | 06/20/1991SE |
| K904881 | Disposable Yankauer Suction TubeGEA · Traditional | Pilling Medical S.A. | 03/06/1991SE |
| K903416 | Cannula, SurgicalGEA · Traditional | Advantage Diagnostics Corp. | 11/23/1990SE |
| K904218 | Suction SystemGEA · Traditional | Axiom Medical, Inc. | 10/31/1990SE |
| K901718 | Klein Lamprey-Cannula(Tm)GEA · Traditional | Jeff Klein Surgical, Inc. | 05/24/1990SE |
| K901717 | Klein Micro-Cannula(Tm)GEA · Traditional | Jeff Klein Surgical, Inc. | 05/24/1990SE |
More from Jeff Klein Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992353 | Blunt Tip Trocar PortGCJ · Traditional | 07/30/1999SE |
| K981700 | Vasoview Dissection/Vessel Harvesting SystemGCJ · Special | 05/29/1998SE |
| K972685 | Origin Ligator DeviceGCJ · Traditional | 10/01/1997SE |
| K970611 | Origin Cardiac Stablizer OccluderDXC · Traditional | 08/19/1997SE |
| K965121 | CannulaHET · Traditional | 03/20/1997SE |
| 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 |
Questions and answers
When was Origin Secondary Cannula and Trocar cleared by the FDA?
Origin Secondary Cannula and Trocar (K922460) received a 510(k) decision of Substantially Equivalent on September 16, 1992, 113 days after the submission was received.
What is the product code of K922460?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.