FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
K Number: K021929
·
Decision Sep 10, 2002
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
19
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
- K Number
- K021929
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axya Medical, Inc.
- Date Received
- June 12, 2002
- Decision Date
- September 10, 2002
- 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
FDA 510(k)
FDA Unclassified
·Unknown
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)
FDA 510(k)
FDA Unclassified
·Unknown
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k)
FDA Unclassified
·Unknown
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 Axya Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070773 | AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR | Oct 11, 2007 | Substantially Equivalent |
| K070253 | AXYA SUTURE WELDING SYSTEM AND KIT | Jul 11, 2007 | Substantially Equivalent |
| K063194 | TUFFLEX POLYESTER SUTURE | Dec 4, 2006 | Substantially Equivalent |
| K060165 | AXYAFLEX POLYESTER SUTURE | Sep 1, 2006 | Substantially Equivalent |
| K060970 | AXYALOOP NONABSORBABLE BONE ANCHOR | Jul 5, 2006 | Substantially Equivalent |
| K052491 | AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR | Oct 7, 2005 | Substantially Equivalent |
| K051983 | MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR | Aug 5, 2005 | Substantially Equivalent |
| K051250 | AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR | Jun 9, 2005 | Substantially Equivalent |
| K041698 | AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR | Oct 5, 2004 | Substantially Equivalent |
| K022207 | AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM | Oct 4, 2002 | Substantially Equivalent |