FDA product code GCZ: Retainer, Surgical
GCZ is the FDA product code for retainer, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under GCZ, from 3 different applicants. The average 510(k) review took 44 days (median 49). FDA has posted 6 recalls for GCZ devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Retainer, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| 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 GCZ clearance
Top GCZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adept-Med Intl., Inc. | 3 | 1989-07-14 |
| Jain Surgical Equipment, Inc. | 1 | 1990-11-29 |
| Edward Weck, Inc. | 1 | 1980-08-04 |
Most recent GCZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904536 | Jain Surgical Equipment, Inc. | JAIN GRAFT ASSIST | 1990-11-29 | 56 |
| K893870 | Adept-Med Intl., Inc. | ADAMS BREAST IMPLANT PROTECTOR | 1989-07-14 | 49 |
| K870809 | Adept-Med Intl., Inc. | MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 | 1987-03-19 | 16 |
| K802806 | Adept-Med Intl., Inc. | VISECERA RETAINER | 1981-01-23 | 77 |
| K801610 | Edward Weck, Inc. | CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR | 1980-08-04 | 20 |
Recalls for GCZ devices
6 product recalls in 1 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2025-08-21.
| Year | Recalls |
|---|---|
| 2025 | 6 |
Frequently asked questions
What is FDA product code GCZ?
GCZ is the FDA product code for retainer, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GCZ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GCZ?
Across 5 cleared submissions the average was 44 days from receipt to decision (median 49).
Which companies have the most GCZ clearances?
Adept-Med Intl., Inc. (3); Jain Surgical Equipment, Inc. (1); Edward Weck, Inc. (1).
Have GCZ devices been recalled?
Yes: 6 product recalls across 1 recall events; the most recent began 2025-08-21.
Next steps
- Run an FDA pathway report with predicate devices for product code GCZ
- Run a recall and safety report across every GCZ manufacturer
- Watch product code GCZ 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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