FDA product code GDG: Hook, Surgical, General & Plastic Surgery
GDG is the FDA product code for hook, 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 10 510(k) submissions under GDG, from 8 different applicants. The average 510(k) review took 44 days (median 28). FDA has posted 7 recalls for GDG devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Hook, 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 GDG clearance
Top GDG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 3 | 1978-06-14 |
| United States Surgical, A Division of Tyco Healthc | 1 | 1990-04-16 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-04-12 |
| Cedar Surgical, Inc. | 1 | 1986-12-12 |
| Brimfield Scientific Instruments | 1 | 1984-09-25 |
3 more applicants have GDG clearances. See the full list in Caduvo.
Most recent GDG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900069 | United States Surgical, A Division of Tyco Healthc | MODIFIED PGL ABSORBABLE STAPLE* | 1990-04-16 | 102 |
| K891898 | Zinnanti Surgical Instruments, Inc. | SKIN HOOKS, VARIOUS TYPES | 1989-04-12 | 19 |
| K864425 | Cedar Surgical, Inc. | RAYLOR(TM) DISSECTING HOOK | 1986-12-12 | 32 |
| K843136 | Brimfield Scientific Instruments | BRIMFIELD CANNULATED GRASPING HOOKS | 1984-09-25 | 47 |
| K841010 | Premier Dental Products Co. | SURGICAL HOOKS, VARIOUS | 1984-05-01 | 53 |
Recalls for GDG devices
7 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 3 |
Frequently asked questions
What is FDA product code GDG?
GDG is the FDA product code for hook, 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 GDG?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDG?
Across 10 cleared submissions the average was 44 days from receipt to decision (median 28).
Which companies have the most GDG clearances?
Edward Weck, Inc. (3); United States Surgical, A Division of Tyco Healthc (1); Zinnanti Surgical Instruments, Inc. (1); Cedar Surgical, Inc. (1); Brimfield Scientific Instruments (1).
Have GDG devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GDG
- Run a recall and safety report across every GDG manufacturer
- Watch product code GDG 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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