BOVIE ULTRASONIC SURGICAL SYSTEM
FDA 510(k) clearance K855138 · decided 1986-11-10
Clearance details
- K-number
- K855138
- Device name
- BOVIE ULTRASONIC SURGICAL SYSTEM
- Applicant
- Clinical Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-23
- Decision date
- 1986-11-10
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- LBK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DISSECTRON PORTABLE UNIT (K972612) | Satelec | 1997-10-08 |
| OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (K962952) | Olympus Optical, Co. | 1996-11-29 |
| CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR (K884413) | Valleylab, Inc. | 1988-12-02 |
| CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (K884412) | Valleylab, Inc. | 1988-12-02 |
| AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT (K883522) | Amerimed US Corp. | 1988-09-30 |
| COOPER LASER SONICS CUSA MODEL 200 (K853143) | Cooper Lasersonics, Inc. | 1985-10-16 |
Recalls involving this device
No recalls on record reference this clearance.