FDA product code GCX: Apparatus, Suction, Operating-Room, Wall Vacuum Powered
GCX is the FDA product code for apparatus, suction, operating-room, wall vacuum powered. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel. FDA has cleared 87 510(k) submissions under GCX, from 62 different applicants. The average 510(k) review took 101 days (median 74). FDA has posted 38 recalls for GCX devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
| 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 GCX clearance
Top GCX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Westmark, Sterile Packing Systems, Inc. (Sps) | 6 | 1990-02-08 |
| Deknatel, Inc. | 4 | 1993-07-28 |
| Stryker Endoscopy | 3 | 2004-12-09 |
| Sorensen Research | 3 | 1984-01-25 |
| Sherwood Medical Co. | 3 | 1981-11-16 |
57 more applicants have GCX clearances. See the full list in Caduvo.
Most recent GCX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042454 | Stryker Endoscopy | STRYKER CASSETTE PUMP | 2004-12-09 | 90 |
| K992126 | Circon Corp. | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | 1999-08-03 | 41 |
| K972074 | Walter Lorenz Surgical, Inc. | SUCTION INSTRUMENTATION | 1997-07-25 | 52 |
| K971022 | Chase Medical, Inc. | CHASE SUCKER | 1997-04-17 | 28 |
| K964127 | Allegiance Healthcare Corp. | MEDI-VAC FLEXI-CLEAR SUCTION HANDLE | 1996-12-31 | 77 |
Recalls for GCX devices
38 product recalls in 13 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2026-06-08.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code GCX?
GCX is the FDA product code for apparatus, suction, operating-room, wall vacuum powered. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.
What device class is GCX?
Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GCX?
Across 87 cleared submissions the average was 101 days from receipt to decision (median 74).
Which companies have the most GCX clearances?
Westmark, Sterile Packing Systems, Inc. (Sps) (6); Deknatel, Inc. (4); Stryker Endoscopy (3); Sorensen Research (3); Sherwood Medical Co. (3).
Have GCX devices been recalled?
Yes: 38 product recalls across 13 recall events; the most recent began 2026-06-08.
Next steps
- Run an FDA pathway report with predicate devices for product code GCX
- Run a recall and safety report across every GCX manufacturer
- Watch product code GCX 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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