5 in 1 Connector
FDA 510(k) K861757 · Jackson Plastics, Inc.
510(k) numberK861757
Submission
- Device name
- 5 in 1 Connector
- Applicant
- Jackson Plastics, Inc.
Jackson, TN, US - Received
- May 6, 1986
- Decision date
- June 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAZ – Tubing, Noninvasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code GAZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952605 | Suction/Irrigator Tubing KitGAZ · Traditional | Surgical Laser Technologies, Inc. | 09/15/1995SE |
| K945978 | Tubing, NoninvasiveGAZ · Traditional | Endoscopic Technologies, Inc. | 01/11/1995SE |
| K930512 | Suction/Irrigation Y Tubing Set W/Trumpet ValvesGAZ · Traditional | Core Dynamics, Inc. | 07/23/1993SE |
| K911865 | Nortec Connecting Tube SetGAZ · Traditional | North American Sterilization & Packaging Co. | 11/01/1991SE |
| K910471 | Medid-Vac Clear Nonconductive Connecting TubeGAZ · Traditional | Baxter Healthcare Corp | 03/08/1991SE |
| K910171 | Maxi-Flow Suction Set W/Y ConnectorGAZ · Traditional | Adler Instrument Co. | 02/01/1991SE |
| K910170 | Maxi-Flow Suction Set 12 Ft.GAZ · Traditional | Adler Instrument Co. | 02/01/1991SE |
| K882315 | Vir-A-Vac EmptyGAZ · Traditional | Viratec Corp. | 09/26/1988SE |
| K883473 | Surgical Connecting TubesGAZ · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 08/25/1988SE |
| K864964 | 5 - in - 1 ConnectorGAZ · Traditional | Medovations, Inc. | 01/20/1987SE |
Questions and answers
When was 5 in 1 Connector cleared by the FDA?
5 in 1 Connector (K861757) received a 510(k) decision of Substantially Equivalent on June 6, 1986, 31 days after the submission was received.
What is the product code of K861757?
The FDA product code is GAZ – Tubing, Noninvasive, a Class II (moderate risk) device regulated under 21 CFR 880.6740.