FDA product code EMD: Hemostat, Surgical
EMD is the FDA product code for hemostat, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under EMD, from 2 different applicants. The average 510(k) review took 12 days (median 12).
Classification
| Field | Value |
|---|---|
| Device name | Hemostat, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EMD clearance
Top EMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| S.T.S Instruments | 1 | 1992-03-13 |
| Deringer-Ney, Inc. | 1 | 1977-01-31 |
Most recent EMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920883 | S.T.S Instruments | HEMOSTAT, SURGICAL (VARIOUS TYPES) | 1992-03-13 | 16 |
| K770158 | Deringer-Ney, Inc. | HEMOSTAT | 1977-01-31 | 7 |
Recalls for EMD devices
openFDA lists no recalls for product code EMD.
Frequently asked questions
What is FDA product code EMD?
EMD is the FDA product code for hemostat, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMD?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMD?
Across 2 cleared submissions the average was 12 days from receipt to decision (median 12).
Which companies have the most EMD clearances?
S.T.S Instruments (1); Deringer-Ney, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EMD
- Run a recall and safety report across every EMD manufacturer
- Watch product code EMD 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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