FDA product code GDJ: Clamp, Surgical, General & Plastic Surgery
GDJ is the FDA product code for clamp, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 32 510(k) submissions under GDJ, from 25 different applicants. The average 510(k) review took 60 days (median 34). FDA has posted 9 recalls for GDJ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Surgical, General & Plastic Surgery |
| 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 GDJ clearance
Top GDJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 5 | 1978-02-28 |
| United States Surgical, A Division of Tyco Healthc | 2 | 1990-04-09 |
| Conphar, Inc. | 2 | 1979-09-21 |
| Med General | 2 | 1978-12-15 |
| Standard Bariatrics | 1 | 2016-05-02 |
20 more applicants have GDJ clearances. See the full list in Caduvo.
Most recent GDJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153358 | Standard Bariatrics | Standard Clamp | 2016-05-02 | 164 |
| K930315 | Thomasville Medical Assoc. | THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE | 1994-02-04 | 378 |
| K924223 | Mar-Med Co. | MAR-MED LIVER STRAP | 1993-03-18 | 209 |
| K922659 | Miltex Instrument Co. | GENERAL SURGERY CLAMP AND NEEDLE HOLDER | 1992-07-21 | 48 |
| K914913 | Ideal Medical, Inc. | GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST | 1991-12-31 | 60 |
Recalls for GDJ devices
9 product recalls in 6 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code GDJ?
GDJ is the FDA product code for clamp, surgical, general & plastic surgery. 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 GDJ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDJ?
Across 32 cleared submissions the average was 60 days from receipt to decision (median 34).
Which companies have the most GDJ clearances?
Edward Weck, Inc. (5); United States Surgical, A Division of Tyco Healthc (2); Conphar, Inc. (2); Med General (2); Standard Bariatrics (1).
Have GDJ devices been recalled?
Yes: 9 product recalls across 6 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GDJ
- Run a recall and safety report across every GDJ manufacturer
- Watch product code GDJ 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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