FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SURGICAL ASPIRATOR KIT
K Number: K904010
·
Decision Nov 21, 1990
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
10
Review Days
84
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Basic Information
- Device Name
- SURGICAL ASPIRATOR KIT
- K Number
- K904010
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Surgeon Surgical Instrumentation, Inc.
- Date Received
- August 29, 1990
- Decision Date
- November 21, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.
CUSA® Clarity Ultrasonic Surgical Aspirator System
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SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
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FDA Unclassified
·Unknown
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k)
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Tenex 2nd Generation System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Surgeon Surgical Instrumentation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954241 | SURGIN GENISIS PHACOEMULSIFIER | Dec 1, 1995 | Substantially Equivalent |
| K932281 | VERRES NEEDLE | Aug 6, 1993 | Substantially Equivalent |
| K922038 | CO2 INSUFFLATION TUBING | Oct 13, 1992 | Substantially Equivalent |
| K890447 | HEMORRHAGE OCCLUDOR | Feb 23, 1989 | Substantially Equivalent |
| K880543 | UNI-PORT | Jul 1, 1988 | Substantially Equivalent |
| K881232 | SURGIN EYE SHIELD | Apr 13, 1988 | Substantially Equivalent |
| K861203 | MULTI-SPIKE | Apr 28, 1986 | Substantially Equivalent |
| K852229 | STERILE EYE PACKS OR TRAYS | Jun 7, 1985 | Substantially Equivalent |
| K830859 | I/A KIT | May 2, 1983 | Substantially Equivalent |