FDA product code GBJ: Prosthesis, Adhesive, External
GBJ is the FDA product code for prosthesis, adhesive, external. It is a Class I device, regulated under 21 CFR 878.3750 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under GBJ, from 4 different applicants. The average 510(k) review took 31 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Adhesive, External |
| Device class | Class I |
| Regulation | 21 CFR 878.3750 |
| 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 GBJ clearance
Top GBJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trulife , Ltd. | 1 | 1993-12-10 |
| Minnesota Scientific, Inc. | 1 | 1981-02-26 |
| Whitman Medical Corp. | 1 | 1979-06-05 |
| Jelco Laboratories | 1 | 1979-02-26 |
Most recent GBJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934970 | Trulife , Ltd. | DUET | 1993-12-10 | 53 |
| K810282 | Minnesota Scientific, Inc. | OPERATING TABLE ACCESSORY CLAMP | 1981-02-26 | 24 |
| K790946 | Whitman Medical Corp. | GORDON IVS INTRAVENOUS STABILIZER | 1979-06-05 | 18 |
| K790186 | Jelco Laboratories | PROTECTIVSTABILIZER | 1979-02-26 | 28 |
Recalls for GBJ devices
openFDA lists no recalls for product code GBJ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system
Frequently asked questions
What is FDA product code GBJ?
GBJ is the FDA product code for prosthesis, adhesive, external. It is a Class I device, regulated under 21 CFR 878.3750 and reviewed by the General and Plastic Surgery panel.
What device class is GBJ?
Class I, regulation 21 CFR 878.3750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBJ?
Across 4 cleared submissions the average was 31 days from receipt to decision (median 26).
Which companies have the most GBJ clearances?
Trulife , Ltd. (1); Minnesota Scientific, Inc. (1); Whitman Medical Corp. (1); Jelco Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GBJ
- Run a recall and safety report across every GBJ manufacturer
- Watch product code GBJ 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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