FDA product code GZX: Instrument, Microsurgical
GZX is the FDA product code for instrument, microsurgical. It is a Class I device, regulated under 21 CFR 882.4525 and reviewed by the Neurology panel. FDA has cleared 13 510(k) submissions under GZX, from 9 different applicants. The average 510(k) review took 76 days (median 83). FDA has posted 1 recall for GZX devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Microsurgical |
| Device class | Class I |
| Regulation | 21 CFR 882.4525 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GZX clearance
Top GZX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keeler Instruments, Inc. | 4 | 1985-11-07 |
| Downs Surgical , Ltd. | 2 | 1987-12-17 |
| American Russian Medical Services, Inc. | 1 | 1993-07-20 |
| Clarus Medical Systems, Inc. | 1 | 1993-04-07 |
| O.R. Specialties, Inc. | 1 | 1991-08-26 |
4 more applicants have GZX clearances. See the full list in Caduvo.
Most recent GZX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932169 | American Russian Medical Services, Inc. | MICROSURGICAL INSTRUMENTS | 1993-07-20 | 76 |
| K926048 | Clarus Medical Systems, Inc. | CLARUS ENDOSCOPIC BALL PROBE | 1993-04-07 | 127 |
| K911932 | O.R. Specialties, Inc. | J105 JAMES SURGICAL SYSTEM I/A PACK | 1991-08-26 | 118 |
| K890216 | Kinetic Medical Products | MICROSURGICAL KERATOME | 1989-02-16 | 29 |
| K873934 | Downs Surgical , Ltd. | RANGE OF CROCODILE ACTION INSTRUMENTS | 1987-12-17 | 83 |
Recalls for GZX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-01-22.
Frequently asked questions
What is FDA product code GZX?
GZX is the FDA product code for instrument, microsurgical. It is a Class I device, regulated under 21 CFR 882.4525 and reviewed by the Neurology panel.
What device class is GZX?
Class I, regulation 21 CFR 882.4525. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GZX?
Across 13 cleared submissions the average was 76 days from receipt to decision (median 83).
Which companies have the most GZX clearances?
Keeler Instruments, Inc. (4); Downs Surgical , Ltd. (2); American Russian Medical Services, Inc. (1); Clarus Medical Systems, Inc. (1); O.R. Specialties, Inc. (1).
Have GZX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-01-22.
Next steps
- Run an FDA pathway report with predicate devices for product code GZX
- Run a recall and safety report across every GZX manufacturer
- Watch product code GZX 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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