Nortec Connecting Tube Set
FDA 510(k) K911865 · North American Sterilization & Packaging Co.
510(k) numberK911865
Submission
- Device name
- Nortec Connecting Tube Set
- Applicant
- North American Sterilization & Packaging Co.
Sparta, NJ, US - Received
- April 26, 1991
- Decision date
- November 1, 1991
- 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 |
| K930512 | Suction/Irrigation Y Tubing Set W/Trumpet ValvesGAZ · Traditional | Core Dynamics, Inc. | 07/23/1993SE |
| 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 |
|---|---|---|
| K964231 | Nasp Hydrocolloid Dressing (Regular or Thin)KMF · Traditional | 03/10/1997SE |
| K963753 | Nasp Transparent DressingMGP · Traditional | 11/29/1996SE |
| K962352 | Hydrogel Skin DressingNAE · Traditional | 08/02/1996SE |
| K925593 | Nortec Sterile Water for Device IrrigationLDQ · Traditional | 12/03/1993SE |
| K925588 | Nortec Ster SALINE-O.9% Sodium Chlor for Dev IrriLDQ · Traditional | 12/03/1993SE |
| K925161 | Nortec Sterile Water for Catheter Balloon InflatioKNY · Traditional | 07/21/1993SE |
| K911784 | Nortec Robertazzi Nasopharyngeal AirwayBTQ · Traditional | 09/23/1991SE |
| K910691 | Nortec Ureteral StentFAD · Traditional | 08/15/1991SE |
| K903162 | Flexible Endoscopic ElectrodesFAS · Traditional | 12/18/1990SE |
| K903156 | Control-Tip Cystoscopic ElectrodesFAS · Traditional | 12/18/1990SE |
Questions and answers
When was Nortec Connecting Tube Set cleared by the FDA?
Nortec Connecting Tube Set (K911865) received a 510(k) decision of Substantially Equivalent on November 1, 1991, 189 days after the submission was received.
What is the product code of K911865?
The FDA product code is GAZ – Tubing, Noninvasive, a Class II (moderate risk) device regulated under 21 CFR 880.6740.