FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
K Number: K070360
·
Decision Aug 7, 2007
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
18
Review Days
181
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Basic Information
- Device Name
- KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
- K Number
- K070360
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kirwan Surgical Products, Inc.
- Date Received
- February 7, 2007
- Decision Date
- August 7, 2007
- 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 Kirwan Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE | Aug 19, 2010 | Substantially Equivalent |
| K060915 | KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS | Apr 17, 2007 | Substantially Equivalent |
| K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | Mar 9, 2007 | Substantially Equivalent |
| K052203 | AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 | Oct 20, 2005 | Substantially Equivalent |
| K023482 | AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 | Jan 15, 2003 | Substantially Equivalent |
| K992218 | DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 | Jul 30, 1999 | Substantially Equivalent |
| K982176 | KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR | Sep 18, 1998 | Substantially Equivalent |
| K971341 | KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR | May 22, 1997 | Substantially Equivalent |
| K965241 | BIPOLAR SUCTION COAGULATOR | Feb 28, 1997 | Substantially Equivalent |
| K962678 | BIPOLAR PENCIL COAGULATOR | Aug 14, 1996 | Substantially Equivalent |