FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K Number: K883091
·
Decision Oct 14, 1988
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
78
Review Days
84
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Basic Information
- Device Name
- SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
- K Number
- K883091
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Sharplan Lasers, Inc.
- Date Received
- July 22, 1988
- Decision Date
- October 14, 1988
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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CUSA® Clarity Ultrasonic Surgical Aspirator System
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Ultrasonic Surgical System
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Other Clearances by Sharplan Lasers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973354 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | Dec 4, 1997 | Substantially Equivalent |
| K972099 | SHARPLAN EPITOUCH RUBY LASER SYSTEM | Aug 27, 1997 | Substantially Equivalent |
| K971874 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | Aug 18, 1997 | Substantially Equivalent |
| K971648 | SHARPLAN ERBIUM: YAG LASER (4020) | Jul 23, 1997 | Substantially Equivalent |
| K971743 | SHARPLAN CO2 SURGICAL LASER SYSTEM | Jul 18, 1997 | Substantially Equivalent |
| K962446 | SHARPLAN RUBY LASER SYSTEM | Mar 7, 1997 | Substantially Equivalent |
| K963229 | SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS | Nov 5, 1996 | Substantially Equivalent |
| K961935 | SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER | Nov 1, 1996 | Substantially Equivalent |
| K962974 | SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) | Aug 21, 1996 | Substantially Equivalent |
| K961279 | SHARPLAN LASERS, INC. RUBY LASER SYSTEM | Jun 18, 1996 | Substantially Equivalent |