Neurosurgical Ultrasonic Instruments
Neurosurgical ultrasonic instruments are devices used in neurosurgery to fragment and aspirate tissue, such as brain tumors, using high-frequency ultrasonic energy. This device type is currently unclassified by the FDA, meaning it has not been assigned a definitive risk class and its regulatory requirements remain under evaluation. The product code is LBK, with no regulation number or medical specialty formally assigned. No special risk flags apply.
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Basic Information
- Product Code
- LBK
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972612 | DISSECTRON PORTABLE UNIT | Oct 08, 1997 | Substantially Equivalent | Satelec |
| K962952 | OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) | Nov 29, 1996 | Substantially Equivalent | Olympus Optical, Co. |
| K884413 | CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR | Dec 02, 1988 | Substantially Equivalent | Valleylab, Inc. |
| K884412 | CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. | Dec 02, 1988 | Substantially Equivalent | Valleylab, Inc. |
| K883522 | AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT | Sep 30, 1988 | Substantially Equivalent | Amerimed US Corp. |
| K855138 | BOVIE ULTRASONIC SURGICAL SYSTEM | Nov 10, 1986 | Substantially Equivalent | Clinical Technology Corp. |
| K853143 | COOPER LASER SONICS CUSA MODEL 200 | Oct 16, 1985 | Substantially Equivalent | Cooper Lasersonics, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.