Cannula, Surgical
FDA 510(k) K903416 · Advantage Diagnostics Corp.
510(k) numberK903416
Submission
- Device name
- Cannula, Surgical
- Applicant
- Advantage Diagnostics Corp.
Tucson, AZ, US - Received
- July 30, 1990
- Decision date
- November 23, 1990
- 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 |
| 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 |
|---|---|---|
| K023712 | Advantage Multiple Drugs of Abuse TestDKZ · Traditional | 01/31/2003SE |
| K013778 | Peace of Mind Home Drug TestMVO · Traditional | 02/07/2002SE |
| K011962 | Advantage Marijuana (THC) and Cocaine Home Drug TestDIO · Traditional | 08/09/2001SE |
| K010921 | Advantage Marijuana (THC) Home Drug TestLDJ · Traditional | 06/25/2001SE |
| K003708 | Advantage Thc/Cocaine TestDIO · Traditional | 01/22/2001SE |
| K001567 | Advantage THC TestLDJ · Traditional | 06/19/2000SE |
| K994227 | Advantage HCG Test (Urine/Serum)JHI · Traditional | 02/03/2000SE |
| K991883 | Redi-Test OpiatesDJG · Traditional | 09/15/1999SE |
| K881369 | Advance Diagnostics Disposable EyecupLXQ · Traditional | 05/13/1988SE |
Questions and answers
When was Cannula, Surgical cleared by the FDA?
Cannula, Surgical (K903416) received a 510(k) decision of Substantially Equivalent on November 23, 1990, 116 days after the submission was received.
What is the product code of K903416?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.