FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SONOSURG ULTRASONIC SURGICAL SYSTEM
K Number: K041566
·
Decision Sep 8, 2004
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- SONOSURG ULTRASONIC SURGICAL SYSTEM
- K Number
- K041566
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aomori Olympus Co., Ltd.
- Date Received
- June 10, 2004
- Decision Date
- September 8, 2004
- 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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Other Clearances by Aomori Olympus Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K042160 | SONOSURG TROCAR | Jan 25, 2005 | Substantially Equivalent |
| K033333 | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B | Nov 14, 2003 | Substantially Equivalent |
| K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Oct 1, 2003 | Substantially Equivalent |
| K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Aug 29, 2003 | Substantially Equivalent |
| K021672 | PANCREATIC DRAINAGE TUBE | Apr 16, 2003 | Substantially Equivalent |
| K022446 | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C | Mar 28, 2003 | Substantially Equivalent |