Newman Cannulae System (NCS)
FDA 510(k) K862936 · Byron Medical
510(k) numberK862936
Submission
- Device name
- Newman Cannulae System (NCS)
- Applicant
- Byron Medical
Tucson, AZ, US - Received
- August 4, 1986
- Decision date
- August 14, 1986
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
|---|---|---|
| K040149 | Psi-Tec Peristaltic Infiltration PumpFRN · Traditional | 06/03/2004SE |
| K001803 | Accelerator Reciprocating CannulaQPB · Traditional | 08/04/2000SE |
| K981215 | Psi-Tec Liposuction AspiratorQPB · Traditional | 07/01/1998SE |
| K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesQPB · Traditional | 06/30/1998SE |
| K980738 | Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationFRN · Traditional | 06/16/1998SE |
| K980392 | Psi-Tec AspiratorBTA · Traditional | 03/05/1998SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | 02/10/1998SE |
| K973133 | Big Bag 3000 Pressure InfusorFRN · Traditional | 09/12/1997ST |
| K934179 | Disposable Bag DecanterKPE · Traditional | 05/23/1994SE |
| K934233 | Zara Zone IV Malar Implant ModificationLZK · Traditional | 02/03/1994SE |
Questions and answers
When was Newman Cannulae System (NCS) cleared by the FDA?
Newman Cannulae System (NCS) (K862936) received a 510(k) decision of Substantially Equivalent for Some Indications on August 14, 1986, 10 days after the submission was received.
What is the product code of K862936?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.