Suction/Irrigator Tubing Kit
FDA 510(k) K952605 · Surgical Laser Technologies, Inc.
510(k) numberK952605
Submission
- Device name
- Suction/Irrigator Tubing Kit
- Applicant
- Surgical Laser Technologies, Inc.
Oaks, PA, US - Received
- June 6, 1995
- Decision date
- September 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K861757 | 5 in 1 ConnectorGAZ · Traditional | Jackson Plastics, Inc. | 06/06/1986SE |
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| K010041 | SLT Diffuser FiberGEX · Traditional | 03/07/2001SE |
| K984018 | Hemosleeve, Model 4.0MM, 5.5MMGEI · Traditional | 03/15/1999SE |
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| K972548 | SLT CL MD Contact Laser SystemGEX · Traditional | 04/21/1998SE |
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Questions and answers
When was Suction/Irrigator Tubing Kit cleared by the FDA?
Suction/Irrigator Tubing Kit (K952605) received a 510(k) decision of Substantially Equivalent on September 15, 1995, 101 days after the submission was received.
What is the product code of K952605?
The FDA product code is GAZ – Tubing, Noninvasive, a Class II (moderate risk) device regulated under 21 CFR 880.6740.