FDA product code LBK: Neurosurgical Ultrasonic Instruments
LBK is the FDA product code for neurosurgical ultrasonic instruments. It is a Unclassified device, reviewed by the Neurology panel. FDA has cleared 7 510(k) submissions under LBK, from 6 different applicants. The average 510(k) review took 106 days (median 79). FDA has posted 1 recall for LBK devices.
Classification
| Field | Value |
|---|---|
| Device name | Neurosurgical Ultrasonic Instruments |
| Device class | Unclassified |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LBK clearance
Top LBK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Valleylab, Inc. | 2 | 1988-12-02 |
| Satelec | 1 | 1997-10-08 |
| Olympus Optical, Co. | 1 | 1996-11-29 |
| Amerimed US Corp. | 1 | 1988-09-30 |
| Clinical Technology Corp. | 1 | 1986-11-10 |
1 more applicants have LBK clearances. See the full list in Caduvo.
Most recent LBK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972612 | Satelec | DISSECTRON PORTABLE UNIT | 1997-10-08 | 86 |
| K962952 | Olympus Optical, Co. | OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) | 1996-11-29 | 122 |
| K884412 | Valleylab, Inc. | CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. | 1988-12-02 | 43 |
| K884413 | Valleylab, Inc. | CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR | 1988-12-02 | 43 |
| K883522 | Amerimed US Corp. | AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT | 1988-09-30 | 44 |
Recalls for LBK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-01-07.
Frequently asked questions
What is FDA product code LBK?
LBK is the FDA product code for neurosurgical ultrasonic instruments. It is a Unclassified device, reviewed by the Neurology panel.
What device class is LBK?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBK?
Across 7 cleared submissions the average was 106 days from receipt to decision (median 79).
Which companies have the most LBK clearances?
Valleylab, Inc. (2); Satelec (1); Olympus Optical, Co. (1); Amerimed US Corp. (1); Clinical Technology Corp. (1).
Have LBK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-01-07.
Next steps
- Run an FDA pathway report with predicate devices for product code LBK
- Run a recall and safety report across every LBK manufacturer
- Watch product code LBK 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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