Disposable Suction Cannula No. 902008-000
FDA 510(k) K863293 · Lifestream Int'L, Inc.
510(k) numberK863293
Submission
- Device name
- Disposable Suction Cannula No. 902008-000
- Applicant
- Lifestream Int'L, Inc.
Sugar Land, TX, US - Received
- August 25, 1986
- Decision date
- September 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K922460 | Origin Secondary Cannula and TrocarGEA · Traditional | Origin Medsystems, Inc. | 09/16/1992SE |
| 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 |
More from Jeff Klein Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964571 | Vision Cardioplegia Delivery SystemDTR · Traditional | 08/08/1997SE |
| K962354 | Diomed 15, 30, 60 Surgical Diode LaserGEX · Traditional | 09/11/1996SE |
| K920178 | Cardiotomy Reservoir W/20 Micron FiliterDTN · Traditional | 05/13/1993SE |
| K920618 | Autotransfusion Suction SetCAC · Traditional | 03/12/1993SE |
| K913181 | Autologous Blood Processing SystemCAC · Traditional | 05/20/1992SE |
| K914396 | Surgi Light Non-Contact FibersGEX · Traditional | 12/23/1991SE |
| K912045 | TMP Pressure Isolatorr, TMP Pressure Monitor SystDXS · Traditional | 10/31/1991SE |
| K911523 | Modification to Model 90-1460 Laser AdapterGEX · Traditional | 04/22/1991SE |
| K910726 | Light-Touch and Surgi Light FibersGEX · Traditional | 03/29/1991SE |
| K904491 | TMP Left Atrial Pressure Cath Cat.# 100-00X-000DQO · Traditional | 02/01/1991SE |
Questions and answers
When was Disposable Suction Cannula No. 902008-000 cleared by the FDA?
Disposable Suction Cannula No. 902008-000 (K863293) received a 510(k) decision of Substantially Equivalent on September 9, 1986, 15 days after the submission was received.
What is the product code of K863293?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.