FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
HS AMICA DEVICES FAMILY
K Number: K150112
·
Decision Sep 10, 2015
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
233
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Basic Information
- Device Name
- HS AMICA DEVICES FAMILY
- K Number
- K150112
- 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
- H.S Hospital Service S.P.A
- Date Received
- January 20, 2015
- Decision Date
- September 10, 2015
- 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 H.S Hospital Service S.P.A
| K Number | Device Name | ||
|---|---|---|---|
| K242029 | TRAP EASY | Oct 9, 2024 | Substantially Equivalent |
| K232072 | AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G | Feb 9, 2024 | Substantially Equivalent |
| K182605 | HS AMICA devices family | Oct 28, 2019 | Substantially Equivalent |
| K083157 | HS AMICA | Sep 29, 2009 | Substantially Equivalent |
| K033616 | TRAPMATIC SYSTEM SET | Mar 1, 2004 | Substantially Equivalent |