FDA product code GDX: Scalpel, One-Piece
GDX is the FDA product code for scalpel, one-piece. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 26 510(k) submissions under GDX, from 26 different applicants. The average 510(k) review took 44 days (median 30). FDA has posted 6 recalls for GDX devices.
Classification
| Field | Value |
|---|---|
| Device name | Scalpel, One-Piece |
| 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 GDX clearance
Top GDX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgistar, Inc. | 1 | 1992-09-09 |
| Micron Technology, Inc. | 1 | 1992-07-30 |
| Icn Pharmaceuticals, Inc. | 1 | 1991-10-09 |
| Buckman Co., Inc. | 1 | 1991-04-23 |
| Depuy, Inc. | 1 | 1990-12-13 |
21 more applicants have GDX clearances. See the full list in Caduvo.
Most recent GDX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923689 | Surgistar, Inc. | SURGISTAR BLADES | 1992-09-09 | 47 |
| K921167 | Micron Technology, Inc. | ULTRABLADE | 1992-07-30 | 141 |
| K914086 | Icn Pharmaceuticals, Inc. | ICAN CYLINDRICAL SPONGES | 1991-10-09 | 28 |
| K904505 | Buckman Co., Inc. | CCI CORNEAL SCARIFIER | 1991-04-23 | 203 |
| K905380 | Depuy, Inc. | 1-CUT ACL GRAFT KNIFE | 1990-12-13 | 13 |
Recalls for GDX devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-11-06.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code GDX?
GDX is the FDA product code for scalpel, one-piece. 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 GDX?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDX?
Across 26 cleared submissions the average was 44 days from receipt to decision (median 30).
Which companies have the most GDX clearances?
Surgistar, Inc. (1); Micron Technology, Inc. (1); Icn Pharmaceuticals, Inc. (1); Buckman Co., Inc. (1); Depuy, Inc. (1).
Have GDX devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2017-11-06.
Next steps
- Run an FDA pathway report with predicate devices for product code GDX
- Run a recall and safety report across every GDX manufacturer
- Watch product code GDX 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times