FDA product code GDF: Guide, Needle, Surgical
GDF is the FDA product code for guide, needle, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 28 510(k) submissions under GDF, from 20 different applicants. The average 510(k) review took 83 days (median 69). FDA has posted 20 recalls for GDF devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Guide, Needle, Surgical |
| 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 GDF clearance
Top GDF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 3 | 1989-01-27 |
| Conphar, Inc. | 3 | 1982-06-03 |
| Bip USA, Inc. | 2 | 1994-02-17 |
| Guardian Angel Products, Inc. | 2 | 1993-07-13 |
| E-Z-Em, Inc. | 2 | 1992-04-21 |
15 more applicants have GDF clearances. See the full list in Caduvo.
Most recent GDF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031173 | Needle Tech Products, Inc. | NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 | 2003-07-23 | 100 |
| K950311 | Global Medical Products, Ltd. | GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE | 1995-05-26 | 130 |
| K950007 | United States Surgical, A Division of Tyco Healthc | SURGICAL INSTRUMENT GUIDE | 1995-03-15 | 71 |
| K945124 | Promex, Inc. | BREAST LESION LOCALIZATION NEEDLE | 1994-11-22 | 34 |
| K944942 | Promedical , Ltd. | BREAST LESION LOCALIZATION NEEDLE | 1994-11-04 | 28 |
Recalls for GDF devices
20 product recalls in 10 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-07-07.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code GDF?
GDF is the FDA product code for guide, needle, surgical. 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 GDF?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDF?
Across 28 cleared submissions the average was 83 days from receipt to decision (median 69).
Which companies have the most GDF clearances?
Kinetic Medical Products (3); Conphar, Inc. (3); Bip USA, Inc. (2); Guardian Angel Products, Inc. (2); E-Z-Em, Inc. (2).
Have GDF devices been recalled?
Yes: 20 product recalls across 10 recall events; the most recent began 2023-07-07.
Next steps
- Run an FDA pathway report with predicate devices for product code GDF
- Run a recall and safety report across every GDF manufacturer
- Watch product code GDF 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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