FDA product code GBC: Lamp, Surgical, Incandescent
GBC is the FDA product code for lamp, surgical, incandescent. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under GBC, from 4 different applicants. The average 510(k) review took 35 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Lamp, Surgical, Incandescent |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| 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 GBC clearance
Top GBC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 1 | 1990-02-22 |
| Sil-Med Corp. | 1 | 1983-03-29 |
| Skytron, Div. the Kmw Group, Inc. | 1 | 1981-06-02 |
| Cavitron Corp. | 1 | 1981-02-13 |
Most recent GBC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896961 | Jedmed Instrument Co. | HALUX EXLITE MINOR SURGERY LIGHT | 1990-02-22 | 69 |
| K830610 | Sil-Med Corp. | FLAT SUCTION DRAIN | 1983-03-29 | 32 |
| K811311 | Skytron, Div. the Kmw Group, Inc. | SKYTRON ELITE SURGICAL TABLES | 1981-06-02 | 22 |
| K810207 | Cavitron Corp. | MINOR SURGERY LIGHT | 1981-02-13 | 18 |
Recalls for GBC devices
openFDA lists no recalls for product code GBC.
Frequently asked questions
What is FDA product code GBC?
GBC is the FDA product code for lamp, surgical, incandescent. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is GBC?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBC?
Across 4 cleared submissions the average was 35 days from receipt to decision (median 27).
Which companies have the most GBC clearances?
Jedmed Instrument Co. (1); Sil-Med Corp. (1); Skytron, Div. the Kmw Group, Inc. (1); Cavitron Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GBC
- Run a recall and safety report across every GBC manufacturer
- Watch product code GBC 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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