FDA product code GCB: Needle, Catheter
GCB is the FDA product code for needle, catheter. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under GCB, from 7 different applicants. The average 510(k) review took 93 days (median 84). FDA has posted 8 recalls for GCB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Catheter |
| 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 GCB clearance
Top GCB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Dynamics, Inc. | 2 | 1993-07-22 |
| B.Braun Medical, Inc. | 1 | 2015-11-12 |
| Allegiance Healthcare Corp. | 1 | 1998-01-28 |
| Symbiosis Corp. | 1 | 1992-08-04 |
| Concord Laboratories, Inc. | 1 | 1985-11-13 |
2 more applicants have GCB clearances. See the full list in Caduvo.
Most recent GCB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150800 | B.Braun Medical, Inc. | Valved Safety Centesis Catheter | 2015-11-12 | 231 |
| K974146 | Allegiance Healthcare Corp. | PARACENTESIS CATHETER DEVICE | 1998-01-28 | 86 |
| K930568 | Medical Dynamics, Inc. | ADAIR/VERESS NEEDLE INTRODUCER SET | 1993-07-22 | 177 |
| K923028 | Symbiosis Corp. | TURKEL PNEUMOTHORAX KIT | 1992-08-04 | 42 |
| K900374 | Medical Dynamics, Inc. | ADAIR/VERESS NEEDLE INTRODUCER SET | 1990-04-20 | 84 |
Recalls for GCB devices
8 product recalls in 6 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-03-01.
| Year | Recalls |
|---|---|
| 2020 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code GCB?
GCB is the FDA product code for needle, catheter. 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 GCB?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GCB?
Across 8 cleared submissions the average was 93 days from receipt to decision (median 84).
Which companies have the most GCB clearances?
Medical Dynamics, Inc. (2); B.Braun Medical, Inc. (1); Allegiance Healthcare Corp. (1); Symbiosis Corp. (1); Concord Laboratories, Inc. (1).
Have GCB devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2024-03-01.
Next steps
- Run an FDA pathway report with predicate devices for product code GCB
- Run a recall and safety report across every GCB manufacturer
- Watch product code GCB 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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