FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Habib EUS RFA
K Number: K161305
·
Decision Jul 7, 2016
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
10
Review Days
58
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Basic Information
- Device Name
- Habib EUS RFA
- K Number
- K161305
- 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
- Emcision , Ltd.
- Date Received
- May 10, 2016
- Decision Date
- July 7, 2016
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Emcision , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K180165 | Habib EndoHPB | Mar 20, 2018 | Substantially Equivalent |
| K150029 | Habib EUS RFA | Jun 24, 2015 | Substantially Equivalent |
| K083292 | HABIB ENDOHPB | Jun 10, 2009 | Substantially Equivalent |
| K080717 | HABIB HEXABLATE 10 | Mar 27, 2008 | Substantially Equivalent |
| K073687 | HABIB LAPAROSCOPIC HEXABLATE | Jan 9, 2008 | Substantially Equivalent |
| K072383 | HABIB ENDOBLATE | Nov 29, 2007 | Substantially Equivalent |
| K072126 | HABIB VESEAL | Oct 2, 2007 | Substantially Equivalent |
| K071103 | HABIB HEXABLATE | Jun 27, 2007 | Substantially Equivalent |
| K051420 | HABIB 4X | Aug 15, 2005 | Substantially Equivalent |