FDA product code GWZ: Percussor
GWZ is the FDA product code for percussor. It is a Class I device, regulated under 21 CFR 882.1700 and reviewed by the Neurology panel. FDA has cleared 11 510(k) submissions under GWZ, from 7 different applicants. The average 510(k) review took 36 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Percussor |
| Device class | Class I |
| Regulation | 21 CFR 882.1700 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every GWZ clearance
Top GWZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Imm Enterprises , Ltd. | 3 | 1984-02-23 |
| Conphar, Inc. | 2 | 1981-01-08 |
| Amdia Medical Products | 2 | 1979-08-03 |
| Sandal Surgico | 1 | 1989-03-31 |
| The Huxley Instrument Corp. | 1 | 1985-07-26 |
2 more applicants have GWZ clearances. See the full list in Caduvo.
Most recent GWZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891571 | Sandal Surgico | PERCUSSION HAMMER | 1989-03-31 | 11 |
| K852716 | The Huxley Instrument Corp. | TAYLOR PERCUSSION HAMMER SS 410 OR 420 | 1985-07-26 | 30 |
| K851748 | Artiberia | 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE | 1985-06-13 | 49 |
| K834178 | Imm Enterprises , Ltd. | H.R. JAKOBI SURG. INSTR. #10 34/36 | 1984-02-23 | 94 |
| K840314 | Imm Enterprises , Ltd. | CAT 10-NEUROLOGY DEVICE | 1984-02-23 | 30 |
Recalls for GWZ devices
openFDA lists no recalls for product code GWZ.
Frequently asked questions
What is FDA product code GWZ?
GWZ is the FDA product code for percussor. It is a Class I device, regulated under 21 CFR 882.1700 and reviewed by the Neurology panel.
What device class is GWZ?
Class I, regulation 21 CFR 882.1700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GWZ?
Across 11 cleared submissions the average was 36 days from receipt to decision (median 27).
Which companies have the most GWZ clearances?
Imm Enterprises , Ltd. (3); Conphar, Inc. (2); Amdia Medical Products (2); Sandal Surgico (1); The Huxley Instrument Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GWZ
- Run a recall and safety report across every GWZ manufacturer
- Watch product code GWZ 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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