FDA product code GEA: Cannula, Surgical, General & Plastic Surgery
GEA is the FDA product code for cannula, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 36 510(k) submissions under GEA, from 30 different applicants. The average 510(k) review took 72 days (median 61). FDA has posted 24 recalls for GEA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Surgical, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| 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 GEA clearance
Top GEA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ETHICON, Inc. | 3 | 1992-04-02 |
| Jeff Klein Surgical, Inc. | 3 | 1990-05-24 |
| Axiom Medical, Inc. | 2 | 1990-10-31 |
| Wells Johnson Co. | 2 | 1983-10-20 |
| Aesculap, Inc. | 1 | 2001-03-16 |
25 more applicants have GEA clearances. See the full list in Caduvo.
Most recent GEA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003965 | Aesculap, Inc. | MRI SAFE INSTRUMENTS | 2001-03-16 | 84 |
| K982472 | Genicon, LC | GENICON TROCAR | 1999-02-04 | 204 |
| K954599 | Conmedcorp | CONMED TROGARD ELECTRONIC TROCAR SYSTEM | 1995-11-27 | 55 |
| K922460 | Origin Medsystems, Inc. | ORIGIN SECONDARY CANNULA AND TROCAR | 1992-09-16 | 113 |
| K920110 | ETHICON, Inc. | ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE | 1992-04-02 | 86 |
Recalls for GEA devices
24 product recalls in 10 recall events; 1 initiated in the last five years and 15 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2018 | 14 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code GEA?
GEA is the FDA product code for cannula, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GEA?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GEA?
Across 36 cleared submissions the average was 72 days from receipt to decision (median 61).
Which companies have the most GEA clearances?
ETHICON, Inc. (3); Jeff Klein Surgical, Inc. (3); Axiom Medical, Inc. (2); Wells Johnson Co. (2); Aesculap, Inc. (1).
Have GEA devices been recalled?
Yes: 24 product recalls across 10 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GEA
- Run a recall and safety report across every GEA manufacturer
- Watch product code GEA 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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