GAZ · Tubing, Noninvasive
General Hospital · 21 CFR 880.6740 · Class 2
Overview
| Product Code | GAZ |
|---|---|
| Device Name | Tubing, Noninvasive |
| Regulation | 21 CFR 880.6740 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952605 | SUCTION/IRRIGATOR TUBING KIT | Surgical Laser Technologies, Inc. | Sep 15, 1995 | SESE |
| K945978 | TUBING, NONINVASIVE | Endoscopic Technologies, Inc. | Jan 11, 1995 | SESE |
| K930512 | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES | Core Dynamics, Inc. | Jul 23, 1993 | SESE |
| K911865 | NORTEC CONNECTING TUBE SET | North American Sterilization & Packaging Co. | Nov 1, 1991 | SESE |
| K910471 | MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE | Baxter Healthcare Corp | Mar 8, 1991 | SESE |
| K910171 | MAXI-FLOW SUCTION SET W/Y CONNECTOR | Adler Instrument Co. | Feb 1, 1991 | SESE |
| K910170 | MAXI-FLOW SUCTION SET 12 FT. | Adler Instrument Co. | Feb 1, 1991 | SESE |
| K882315 | VIR-A-VAC EMPTY | Viratec Corp. | Sep 26, 1988 | SESE |
| K883473 | SURGICAL CONNECTING TUBES | Westmark, Sterile Packing Systems, Inc. (Sps) | Aug 25, 1988 | SESE |
| K864964 | 5 - IN - 1 CONNECTOR | Medovations, Inc. | Jan 20, 1987 | SESE |
| K861757 | 5 IN 1 CONNECTOR | Jackson Plastics, Inc. | Jun 6, 1986 | SESE |
| K843476 | PHARMA-PLAST SMOOTH BORE CONNECTORS | Zimmar Consulting , Ltd. | Sep 24, 1984 | SESE |
| K840838 | MMG CONNECTIVE TUBING | Medical Marketing Group | Mar 30, 1984 | SESE |
| K832519 | ASPIRATING TUBING | Wells Johnson Co. | Oct 20, 1983 | SESE |
| K830901 | CONNECTOR 5 IN 1, T-CONNECTOR | Medical Specialists IN Packaging | Apr 6, 1983 | SESE |
| K830835 | STERILE 5 IN 1 CONNECTORS | Abco Dealers, Inc. | Apr 6, 1983 | SESE |
| K830381 | STERILE SAFETY PINS | Devon Industries, Inc. | Mar 24, 1983 | SESE |
| K820004 | PLEUROFIX THORACENTESIS KIT | Burron Medical Products, Inc. | Feb 4, 1982 | SESE |
| K802777 | ARGYLE CONNECT TUBE-CON & NON | Sherwood Medical Co. | Dec 11, 1980 | SESE |
| K802761 | LATEX PENROSE TUBING CAT. #20400,414,416 | American Hospital Supply Corp. | Nov 19, 1980 | SESE |
Top Applicants
- Adler Instrument Co. — 2 clearances
- Norton Performance Plastics Corp. — 2 clearances
- Abco Dealers, Inc. — 1 clearance
- American Hospital Supply Corp. — 1 clearance
- Baxter Healthcare Corp — 1 clearance
