FDA product code MMZ: Table, Cystometric, Electric
MMZ is the FDA product code for table, cystometric, electric. It is a Class II device, regulated under 21 CFR 876.4890 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under MMZ, from 4 different applicants. The average 510(k) review took 84 days (median 66). FDA has posted 5 recalls for MMZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Table, Cystometric, Electric |
| Device class | Class II |
| Regulation | 21 CFR 876.4890 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MMZ clearance
Top MMZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 1 | 2003-11-25 |
| Beta Medical Products, Inc. | 1 | 1995-10-02 |
| Synectics Medical, Inc. | 1 | 1994-11-22 |
| Mdt Corp., Inc. | 1 | 1994-08-26 |
Most recent MMZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033335 | Siemens Medical Solutions USA, Inc. | LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS | 2003-11-25 | 40 |
| K954278 | Beta Medical Products, Inc. | BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 | 1995-10-02 | 19 |
| K942445 | Synectics Medical, Inc. | SYNERGY II | 1994-11-22 | 183 |
| K942485 | Mdt Corp., Inc. | MDT UROLOGY TABLE | 1994-08-26 | 93 |
Recalls for MMZ devices
5 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-08.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code MMZ?
MMZ is the FDA product code for table, cystometric, electric. It is a Class II device, regulated under 21 CFR 876.4890 and reviewed by the Gastroenterology and Urology panel.
What device class is MMZ?
Class II, regulation 21 CFR 876.4890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MMZ?
Across 4 cleared submissions the average was 84 days from receipt to decision (median 66).
Which companies have the most MMZ clearances?
Siemens Medical Solutions USA, Inc. (1); Beta Medical Products, Inc. (1); Synectics Medical, Inc. (1); Mdt Corp., Inc. (1).
Have MMZ devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2017-03-08.
Next steps
- Run an FDA pathway report with predicate devices for product code MMZ
- Run a recall and safety report across every MMZ manufacturer
- Watch product code MMZ 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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