Lamp, Surgical, Incandescent
The Lamp, Surgical, Incandescent (product code GBC) is an incandescent light source used in the operating room to illuminate the surgical field, providing clear visibility for surgeons and staff during general and plastic surgery procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence. The device is regulated under 21 CFR 878.4580 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GBC
- Device Class
- FDA class 2
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K896961 | HALUX EXLITE MINOR SURGERY LIGHT | Feb 22, 1990 | Substantially Equivalent | Jedmed Instrument Co. |
| K830610 | FLAT SUCTION DRAIN | Mar 29, 1983 | Substantially Equivalent | Sil-Med Corp. |
| K811311 | SKYTRON ELITE SURGICAL TABLES | Jun 02, 1981 | Substantially Equivalent | Skytron, Div. the Kmw Group, Inc. |
| K810207 | MINOR SURGERY LIGHT | Feb 13, 1981 | Substantially Equivalent | Cavitron Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.