FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTIFUNCTIONAL LINEAR PEN
K Number: K100501
·
Decision Jun 18, 2010
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
52
Applicant Total
28
Review Days
116
Basic Information
- Device Name
- MULTIFUNCTIONAL LINEAR PEN
- K Number
- K100501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ATRICURE, INC.
- Date Received
- February 22, 2010
- Decision Date
- June 18, 2010
- Product Code
- OCL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | FDA class 2 | General, Plastic Surgery |
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Other Clearances by ATRICURE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | Mar 18, 2016 | Substantially Equivalent |
| K150996 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | Jun 17, 2015 | Substantially Equivalent |
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | Nov 25, 2014 | Substantially Equivalent |
| K142441 | cryoICE croablation probe | Oct 29, 2014 | Substantially Equivalent |
| K142120 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP | Aug 28, 2014 | Substantially Equivalent |
| K140058 | ATRICURE CRYO MODULE SYSTEM | Jan 24, 2014 | Substantially Equivalent |
| K131107 | ATRICLIP GILLINOV-COSGROVE LAA CLIP | May 14, 2013 | Substantially Equivalent |
| K130521 | ISOLATOR LINEAR PEN | Apr 5, 2013 | Substantially Equivalent |
| K122611 | COOLRAIL LINEAR PEN MODEL MCRI | Sep 26, 2012 | Substantially Equivalent |
| K122276 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP | Aug 29, 2012 | Substantially Equivalent |