FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K Number: K031305
·
Decision Sep 23, 2003
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
22
Review Days
152
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Basic Information
- Device Name
- OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K Number
- K031305
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus Optical Co., Ltd.
- Date Received
- April 24, 2003
- Decision Date
- September 23, 2003
- 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 Olympus Optical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | Oct 16, 2003 | Substantially Equivalent |
| K031648 | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V | Jul 24, 2003 | Substantially Equivalent |
| K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE | Jul 16, 2003 | Substantially Equivalent |
| K031347 | ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 | May 9, 2003 | Substantially Equivalent |
| K024138 | HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE | Mar 12, 2003 | Substantially Equivalent |
| K021852 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES | Feb 11, 2003 | Substantially Equivalent |
| K022445 | VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V | Jan 24, 2003 | Substantially Equivalent |
| K024033 | XTJF-160AF DUODENOVIDEOSCOPE | Dec 20, 2002 | Substantially Equivalent |
| K023280 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES | Dec 19, 2002 | Substantially Equivalent |
| K013759 | MSS-28CS-301/701 NEEDLESCOPE | Aug 20, 2002 | Substantially Equivalent |