Prosthesis, Adhesive, External
The Prosthesis, Adhesive, External (product code GBJ) is a non-implanted external prosthetic device that is attached to the body using medical adhesive, intended to replace or restore missing anatomical structures such as ears, noses, or other external features following surgery or trauma. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.3750 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GBJ
- Device Class
- FDA class 1
- Regulation Number
- 878.3750
- 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 |
|---|---|---|---|---|
| K934970 | DUET | Dec 10, 1993 | Substantially Equivalent | Trulife , Ltd. |
| K810282 | OPERATING TABLE ACCESSORY CLAMP | Feb 26, 1981 | Substantially Equivalent | Minnesota Scientific, Inc. |
| K790946 | GORDON IVS INTRAVENOUS STABILIZER | Jun 05, 1979 | Substantially Equivalent | Whitman Medical Corp. |
| K790186 | PROTECTIVSTABILIZER | Feb 26, 1979 | Substantially Equivalent | Jelco Laboratories |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.