FDA product code GCD: Connector, Catheter
GCD is the FDA product code for connector, 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 GCD, from 7 different applicants. The average 510(k) review took 99 days (median 69). FDA has posted 7 recalls for GCD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Connector, 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 GCD clearance
Top GCD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sil-Med Corp. | 2 | 1985-06-04 |
| R-Group Intl. | 1 | 1995-11-28 |
| Luther Medical Products, Inc. | 1 | 1994-12-15 |
| Angiomed U.S., Inc. | 1 | 1986-09-23 |
| Sherwood Medical Industries | 1 | 1976-11-02 |
2 more applicants have GCD clearances. See the full list in Caduvo.
Most recent GCD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952470 | R-Group Intl. | ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. | 1995-11-28 | 186 |
| K940198 | Luther Medical Products, Inc. | L-CATH CONNECTOR ASSEMBLY | 1994-12-15 | 336 |
| K863446 | Angiomed U.S., Inc. | ANGIOMED HIGH PRESSURE CONNECTORS | 1986-09-23 | 15 |
| K851196 | Sil-Med Corp. | INCISION DRAIN | 1985-06-04 | 70 |
| K851921 | Sil-Med Corp. | Y CONNECTOR | 1985-05-17 | 15 |
Recalls for GCD devices
7 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-08-16.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code GCD?
GCD is the FDA product code for connector, 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 GCD?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GCD?
Across 8 cleared submissions the average was 99 days from receipt to decision (median 69).
Which companies have the most GCD clearances?
Sil-Med Corp. (2); R-Group Intl. (1); Luther Medical Products, Inc. (1); Angiomed U.S., Inc. (1); Sherwood Medical Industries (1).
Have GCD devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2022-08-16.
Next steps
- Run an FDA pathway report with predicate devices for product code GCD
- Run a recall and safety report across every GCD manufacturer
- Watch product code GCD 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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