FDA product code GCC: Dilator, Catheter
GCC is the FDA product code for dilator, 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 5 510(k) submissions under GCC, from 3 different applicants. The average 510(k) review took 57 days (median 63). FDA has posted 5 recalls for GCC devices.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, 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 GCC clearance
Top GCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med Institute, Inc. | 2 | 1998-05-26 |
| Medical Engineering and Development Institute | 2 | 1990-08-07 |
| Van-Tec, Inc. | 1 | 1982-05-05 |
Most recent GCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K981061 | Med Institute, Inc. | INTRAVASCULAR RETRIEVAL DEVICE | 1998-05-26 | 64 |
| K922354 | Med Institute, Inc. | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET | 1992-07-30 | 72 |
| K902502 | Medical Engineering and Development Institute | BYRD STAINLESS STEEL DILATOR | 1990-08-07 | 63 |
| K893480 | Medical Engineering and Development Institute | BYRD EXTRACTOR SET | 1989-06-23 | 50 |
| K820865 | Van-Tec, Inc. | VAN-TEC FASCIAL DILATOR | 1982-05-05 | 37 |
Recalls for GCC devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-07-31.
Frequently asked questions
What is FDA product code GCC?
GCC is the FDA product code for dilator, 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 GCC?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GCC?
Across 5 cleared submissions the average was 57 days from receipt to decision (median 63).
Which companies have the most GCC clearances?
Med Institute, Inc. (2); Medical Engineering and Development Institute (2); Van-Tec, Inc. (1).
Have GCC devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2013-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code GCC
- Run a recall and safety report across every GCC manufacturer
- Watch product code GCC 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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