FDA product code GDM: Needle, Aspiration And Injection, Reusable
GDM is the FDA product code for needle, aspiration and injection, reusable. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 48 510(k) submissions under GDM, from 37 different applicants. The average 510(k) review took 70 days (median 54). FDA has posted 4 recalls for GDM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Aspiration And Injection, Reusable |
| 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 GDM clearance
Top GDM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Downs Surgical , Ltd. | 5 | 1990-10-31 |
| Popper & Sons, Inc. | 3 | 1984-10-26 |
| Bioaccess, Inc. | 2 | 1997-06-03 |
| Go Medical Industries Pty. , Ltd. | 2 | 1989-10-06 |
| E.L. Medico Intl., Inc. | 2 | 1988-12-02 |
32 more applicants have GDM clearances. See the full list in Caduvo.
Most recent GDM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071732 | Stemcor Systems, Inc. | MARROWMINER | 2007-09-24 | 90 |
| K971114 | Bioaccess, Inc. | BIOACCESS MARROW HARVEST SYSTEM | 1997-06-03 | 69 |
| K953082 | Baxter Healthcare Corp | ILIAC CREST BONE MARROW ASPIRATION NEEDLE | 1995-09-22 | 81 |
| K953064 | Bioaccess, Inc. | BIOACCESS MARROW HARVEST SYSTEM | 1995-08-07 | 38 |
| K936207 | Gerard Medical, Inc. | ENDO-NEEDLE INSTRUMENT | 1994-06-16 | 169 |
Recalls for GDM devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-06-27.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code GDM?
GDM is the FDA product code for needle, aspiration and injection, reusable. 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 GDM?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDM?
Across 48 cleared submissions the average was 70 days from receipt to decision (median 54).
Which companies have the most GDM clearances?
Downs Surgical , Ltd. (5); Popper & Sons, Inc. (3); Bioaccess, Inc. (2); Go Medical Industries Pty. , Ltd. (2); E.L. Medico Intl., Inc. (2).
Have GDM devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2025-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code GDM
- Run a recall and safety report across every GDM manufacturer
- Watch product code GDM 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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