Maxi-Flow Suction Set W/Y Connector
FDA 510(k) K910171 · Adler Instrument Co.
510(k) numberK910171
Submission
- Device name
- Maxi-Flow Suction Set W/Y Connector
- Applicant
- Adler Instrument Co.
Norcross, GA, US - Received
- January 15, 1991
- Decision date
- February 1, 1991
- 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 |
| 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 |
|---|---|---|
| K910170 | Maxi-Flow Suction Set 12 Ft.GAZ · Traditional | 02/01/1991SE |
| K903209 | Maxi-Flow Insufflator Tubing Set W/FilterHES · Traditional | 12/21/1990SE |
| K903208 | Maxi-Flow Insufflator Tubing SetHES · Traditional | 12/17/1990SE |
| K900913 | Adler Disposable Bipolar CordHQO · Traditional | 04/04/1990SE |
| K841723 | Adler Custom Procedure Packs · Traditional | 08/01/1984SE |
| K833264 | Adler Steam Indicator-Gas IndicatorJOJ · Traditional | 11/03/1983SE |
| K831068 | Container System · Traditional | 05/09/1983SE |
Questions and answers
When was Maxi-Flow Suction Set W/Y Connector cleared by the FDA?
Maxi-Flow Suction Set W/Y Connector (K910171) received a 510(k) decision of Substantially Equivalent on February 1, 1991, 17 days after the submission was received.
What is the product code of K910171?
The FDA product code is GAZ – Tubing, Noninvasive, a Class II (moderate risk) device regulated under 21 CFR 880.6740.