FDA product code GAZ: Tubing, Noninvasive
GAZ is the FDA product code for tubing, noninvasive. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel. FDA has cleared 27 510(k) submissions under GAZ, from 25 different applicants. The average 510(k) review took 48 days (median 34). FDA has posted 14 recalls for GAZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tubing, Noninvasive |
| Device class | Class II |
| Regulation | 21 CFR 880.6740 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GAZ clearance
Top GAZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adler Instrument Co. | 2 | 1991-02-01 |
| Norton Performance Plastics Corp. | 2 | 1979-03-21 |
| Surgical Laser Technologies, Inc. | 1 | 1995-09-15 |
| Endoscopic Technologies, Inc. | 1 | 1995-01-11 |
| Core Dynamics, Inc. | 1 | 1993-07-23 |
20 more applicants have GAZ clearances. See the full list in Caduvo.
Most recent GAZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952605 | Surgical Laser Technologies, Inc. | SUCTION/IRRIGATOR TUBING KIT | 1995-09-15 | 101 |
| K945978 | Endoscopic Technologies, Inc. | TUBING, NONINVASIVE | 1995-01-11 | 34 |
| K930512 | Core Dynamics, Inc. | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES | 1993-07-23 | 172 |
| K911865 | North American Sterilization & Packaging Co. | NORTEC CONNECTING TUBE SET | 1991-11-01 | 189 |
| K910471 | Baxter Healthcare Corp | MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE | 1991-03-08 | 32 |
Recalls for GAZ devices
14 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-01-31.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code GAZ?
GAZ is the FDA product code for tubing, noninvasive. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.
What device class is GAZ?
Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GAZ?
Across 27 cleared submissions the average was 48 days from receipt to decision (median 34).
Which companies have the most GAZ clearances?
Adler Instrument Co. (2); Norton Performance Plastics Corp. (2); Surgical Laser Technologies, Inc. (1); Endoscopic Technologies, Inc. (1); Core Dynamics, Inc. (1).
Have GAZ devices been recalled?
Yes: 14 product recalls across 5 recall events; the most recent began 2025-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code GAZ
- Run a recall and safety report across every GAZ manufacturer
- Watch product code GAZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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