Surgical Connecting Tubes
FDA 510(k) K883473 · Westmark, Sterile Packing Systems, Inc. (Sps)
510(k) numberK883473
Submission
- Device name
- Surgical Connecting Tubes
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
Grand Rapids, MI, US - Received
- August 16, 1988
- Decision date
- August 25, 1988
- 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 |
| K864964 | 5 - in - 1 ConnectorGAZ · Traditional | Medovations, Inc. | 01/20/1987SE |
| K861757 | 5 in 1 ConnectorGAZ · Traditional | Jackson Plastics, Inc. | 06/06/1986SE |
More from Jackson Plastics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896800 | Irrigation TrayKYZ · Traditional | 05/24/1990SESK |
| K896799 | Paracervical/Pudendal TraysCAZ · Traditional | 04/23/1990SE |
| K896559 | Infant Feeding TubeFPD · Traditional | 03/13/1990SE |
| K896794 | Specimen ContainerLIO · Traditional | 03/01/1990SE |
| K896806 | Catheter Plug/ProtectorKNY · Traditional | 02/26/1990SE |
| K896798 | Tracheostomy TrayBTO · Traditional | 02/22/1990SE |
| K896797 | Suction Catheter KitBSY · Traditional | 02/16/1990SE |
| K896215 | Mercy Hip/Knee PackKKX · Traditional | 02/13/1990SE |
| K896804 | ManifoldGCX · Traditional | 02/08/1990SE |
| K896563 | Tubing ConnectorsGCX · Traditional | 02/06/1990SE |
Questions and answers
When was Surgical Connecting Tubes cleared by the FDA?
Surgical Connecting Tubes (K883473) received a 510(k) decision of Substantially Equivalent on August 25, 1988, 9 days after the submission was received.
What is the product code of K883473?
The FDA product code is GAZ – Tubing, Noninvasive, a Class II (moderate risk) device regulated under 21 CFR 880.6740.