FDA product code LRZ: Screwdriver, Surgical
LRZ is the FDA product code for screwdriver, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under LRZ, from 3 different applicants. The average 510(k) review took 31 days (median 30). FDA has posted 6 recalls for LRZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Screwdriver, Surgical |
| 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 LRZ clearance
Top LRZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Optik | 1 | 1989-12-27 |
| Micro-Aire Surgical Instruments, Inc. | 1 | 1987-07-23 |
| Med-Tool, Inc. | 1 | 1987-07-16 |
Most recent LRZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896589 | Optik | MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP | 1989-12-27 | 36 |
| K872490 | Micro-Aire Surgical Instruments, Inc. | 1.1 SCREWDRIVERS | 1987-07-23 | 30 |
| K872387 | Med-Tool, Inc. | STANDARD SCREW DRIVER | 1987-07-16 | 27 |
Recalls for LRZ devices
6 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-11-10.
Frequently asked questions
What is FDA product code LRZ?
LRZ is the FDA product code for screwdriver, surgical. 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 LRZ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LRZ?
Across 3 cleared submissions the average was 31 days from receipt to decision (median 30).
Which companies have the most LRZ clearances?
Optik (1); Micro-Aire Surgical Instruments, Inc. (1); Med-Tool, Inc. (1).
Have LRZ devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2015-11-10.
Next steps
- Run an FDA pathway report with predicate devices for product code LRZ
- Run a recall and safety report across every LRZ manufacturer
- Watch product code LRZ 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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