FDA product code GBB: Chair, Surgical, Ac-Powered
GBB is the FDA product code for chair, surgical, ac-powered. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under GBB, from 6 different applicants. The average 510(k) review took 53 days (median 36). FDA has posted 1 recall for GBB devices.
Classification
| Field | Value |
|---|---|
| Device name | Chair, Surgical, Ac-Powered |
| 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 GBB clearance
Top GBB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 3 | 1982-10-13 |
| Tenet Medical Engineering | 1 | 1996-12-05 |
| Arthro-Medic, Inc. | 1 | 1989-10-10 |
| Medlog GmbH Marketing Services | 1 | 1983-06-02 |
| Midmark Corp. | 1 | 1983-06-02 |
1 more applicants have GBB clearances. See the full list in Caduvo.
Most recent GBB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964102 | Tenet Medical Engineering | TENET TIBIAL FRACTURE SUPPORT | 1996-12-05 | 55 |
| K893598 | Arthro-Medic, Inc. | HYDRAULIC FOOT OPERATED STOOL | 1989-10-10 | 154 |
| K831385 | Midmark Corp. | LITHOTOMY CHAIR #415 | 1983-06-02 | 35 |
| K831325 | Medlog GmbH Marketing Services | NUTROMAT | 1983-06-02 | 38 |
| K822264 | Kelleher Corp. | NAGASHIMA SN OPERATOR'S CHAIR | 1982-10-13 | 76 |
Recalls for GBB devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-11-14.
Frequently asked questions
What is FDA product code GBB?
GBB is the FDA product code for chair, surgical, ac-powered. 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 GBB?
Class I, regulation 21 CFR 878.4960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBB?
Across 8 cleared submissions the average was 53 days from receipt to decision (median 36).
Which companies have the most GBB clearances?
Kelleher Corp. (3); Tenet Medical Engineering (1); Arthro-Medic, Inc. (1); Medlog GmbH Marketing Services (1); Midmark Corp. (1).
Have GBB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code GBB
- Run a recall and safety report across every GBB manufacturer
- Watch product code GBB 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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