FDA product code GDC: Table, Operating-Room, Electrical
GDC is the FDA product code for table, operating-room, electrical. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General and Plastic Surgery panel. FDA has cleared 18 510(k) submissions under GDC, from 12 different applicants. The average 510(k) review took 47 days (median 26). FDA has posted 27 recalls for GDC devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Table, Operating-Room, Electrical |
| Device class | Class I |
| Regulation | 21 CFR 878.4960 |
| 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 GDC clearance
Top GDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Skytron, Div. the Kmw Group, Inc. | 4 | 1994-06-13 |
| Stierlen-Maquet AG | 3 | 1997-03-14 |
| Mdt Corp., Inc. | 2 | 1991-12-19 |
| STERIS Corporation | 1 | 1997-05-15 |
| Allen Medical Systems, Inc. | 1 | 1997-01-08 |
7 more applicants have GDC clearances. See the full list in Caduvo.
Most recent GDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971390 | STERIS Corporation | QUANTUM 3080SP SURGICAL TABLE | 1997-05-15 | 31 |
| K970807 | Stierlen-Maquet AG | MOBILE OPERATING TABLE 1132.01 | 1997-03-14 | 9 |
| K964273 | Allen Medical Systems, Inc. | DURA-BOARD ARMBOARD | 1997-01-08 | 72 |
| K940616 | Skytron, Div. the Kmw Group, Inc. | SKYTRON ELITE 3500 TABLE | 1994-06-13 | 119 |
| K934744 | Midmark Corp. | MIDMARK MAGNUM GENERAL SURGICAL TABLE | 1994-03-28 | 175 |
Recalls for GDC devices
27 product recalls in 18 recall events; 15 initiated in the last five years and 18 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 6 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code GDC?
GDC is the FDA product code for table, operating-room, electrical. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General and Plastic Surgery panel.
What device class is GDC?
Class I, regulation 21 CFR 878.4960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDC?
Across 18 cleared submissions the average was 47 days from receipt to decision (median 26).
Which companies have the most GDC clearances?
Skytron, Div. the Kmw Group, Inc. (4); Stierlen-Maquet AG (3); Mdt Corp., Inc. (2); STERIS Corporation (1); Allen Medical Systems, Inc. (1).
Have GDC devices been recalled?
Yes: 27 product recalls across 18 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code GDC
- Run a recall and safety report across every GDC manufacturer
- Watch product code GDC 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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