Suction/Irrigation Y Tubing Set W/Trumpet Valves
FDA 510(k) K930512 · Core Dynamics, Inc.
510(k) numberK930512
Submission
- Device name
- Suction/Irrigation Y Tubing Set W/Trumpet Valves
- Applicant
- Core Dynamics, Inc.
Jacksonville, FL, US - Received
- February 1, 1993
- Decision date
- July 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K861757 | 5 in 1 ConnectorGAZ · Traditional | Jackson Plastics, Inc. | 06/06/1986SE |
More from Jackson Plastics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992250 | Core Audible Trocar IIGCJ · Traditional | 09/24/1999SE |
| K992190 | Core PouchGCJ · Traditional | 09/01/1999SE |
| K955490 | Laparoscopic KnitterGCJ · Traditional | 01/22/1996SE |
| K953903 | Laparoscopic Trocar Obturator, 5MM, 10/11MM, 10/12MMGCJ · Traditional | 10/20/1995SE |
| K953409 | Laparoscopic TrocarGCJ · Traditional | 10/16/1995SE |
| K950457 | Cannual and Trocar, SuperpubicHET · Traditional | 05/05/1995SE |
| K943172 | Core Dynamics' Laparoscopic Smoke EliminatorGCJ · Traditional | 07/28/1994SE |
| K935826 | Laparoscopic/Suction/Irrigation ProbeGCJ · Traditional | 05/18/1994SE |
| K932118 | Endoscopic Transmural Suture Needle SetHET · Traditional | 03/17/1994SE |
| K932021 | Entree Cannula Fascia AnchorsFBM · Traditional | 01/11/1994SE |
Questions and answers
When was Suction/Irrigation Y Tubing Set W/Trumpet Valves cleared by the FDA?
Suction/Irrigation Y Tubing Set W/Trumpet Valves (K930512) received a 510(k) decision of Substantially Equivalent on July 23, 1993, 172 days after the submission was received.
What is the product code of K930512?
The FDA product code is GAZ – Tubing, Noninvasive, a Class II (moderate risk) device regulated under 21 CFR 880.6740.