FDA product code GBX: Catheter, Irrigation
GBX is the FDA product code for catheter, irrigation. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 77 510(k) submissions under GBX, from 58 different applicants. The average 510(k) review took 122 days (median 83). FDA has posted 82 recalls for GBX devices, 41 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Irrigation |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GBX clearance
Top GBX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sil-Med Corp. | 5 | 1996-06-26 |
| Navarre Biomedical , Ltd. | 5 | 1996-02-07 |
| Axiom Medical, Inc. | 3 | 1997-03-10 |
| Kendall Healthcare Products Co. Div.Of Tyco Health | 3 | 1993-05-12 |
| Mikro-Tek Laboratories | 3 | 1989-12-27 |
53 more applicants have GBX clearances. See the full list in Caduvo.
Most recent GBX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131659 | Moerae Matrix, Inc. | MOERAE VEIN PREPARATION KIT | 2014-03-03 | 270 |
| K082725 | Maquet Cardiovascular, LLC | GRAFTGUARD PRESSURE CONTROLLING SYRINGE | 2008-12-17 | 91 |
| K052286 | The Catheter Exchange, Inc. | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN | 2005-10-21 | 60 |
| K043515 | Vescare, Inc. | GRAFTSAVER | 2005-03-31 | 101 |
| K013417 | Misonix, Inc. | MISONIX IRRIGATION SYSTEM MOEDL BC20P | 2002-01-10 | 87 |
Recalls for GBX devices
82 product recalls in 19 recall events; 41 initiated in the last five years and 41 still open. Most recent: 2026-03-05.
| Year | Recalls |
|---|---|
| 2017 | 11 |
| 2018 | 11 |
| 2019 | 8 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 29 |
| 2024 | 5 |
| 2025 | 6 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code GBX?
GBX is the FDA product code for catheter, irrigation. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is GBX?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBX?
Across 77 cleared submissions the average was 122 days from receipt to decision (median 83).
Which companies have the most GBX clearances?
Sil-Med Corp. (5); Navarre Biomedical , Ltd. (5); Axiom Medical, Inc. (3); Kendall Healthcare Products Co. Div.Of Tyco Health (3); Mikro-Tek Laboratories (3).
Have GBX devices been recalled?
Yes: 82 product recalls across 19 recall events; the most recent began 2026-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code GBX
- Run a recall and safety report across every GBX manufacturer
- Watch product code GBX 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times