FDA product code GDI: Dissector, Surgical, General & Plastic Surgery
GDI is the FDA product code for dissector, 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 7 510(k) submissions under GDI, from 7 different applicants. The average 510(k) review took 54 days (median 43). FDA has posted 6 recalls for GDI devices.
Classification
| Field | Value |
|---|---|
| Device name | Dissector, 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 GDI clearance
Top GDI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Galenica Enterprises, Inc. | 1 | 1989-12-06 |
| Beecher Medical Diagnostic Instrumentation | 1 | 1985-03-18 |
| Ormed Mfg., Inc. | 1 | 1983-10-31 |
| Kelleher Corp. | 1 | 1982-10-06 |
| V. Mueller O.V. Baxter Healthcare Corp. | 1 | 1981-01-29 |
2 more applicants have GDI clearances. See the full list in Caduvo.
Most recent GDI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896383 | Galenica Enterprises, Inc. | DISPOSABLE EXTERNAL CLAMPS | 1989-12-06 | 30 |
| K850288 | Beecher Medical Diagnostic Instrumentation | HEPATIC PARENCHYMAL SUCTION DISSECTOR | 1985-03-18 | 53 |
| K831912 | Ormed Mfg., Inc. | ROUND-BEEHIVE- DISSECTORS 3/8 | 1983-10-31 | 139 |
| K822569 | Kelleher Corp. | TYMPANOPLASTY & SKIN DISSECTORS | 1982-10-06 | 43 |
| K803292 | V. Mueller O.V. Baxter Healthcare Corp. | FIELD SUCTION DISSECTOR | 1981-01-29 | 30 |
Recalls for GDI devices
6 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-11.
Frequently asked questions
What is FDA product code GDI?
GDI is the FDA product code for dissector, 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 GDI?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDI?
Across 7 cleared submissions the average was 54 days from receipt to decision (median 43).
Which companies have the most GDI clearances?
Galenica Enterprises, Inc. (1); Beecher Medical Diagnostic Instrumentation (1); Ormed Mfg., Inc. (1); Kelleher Corp. (1); V. Mueller O.V. Baxter Healthcare Corp. (1).
Have GDI devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2015-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code GDI
- Run a recall and safety report across every GDI manufacturer
- Watch product code GDI 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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