FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sugita AVM Microclip Applier
K Number: K221524
·
Decision Jun 24, 2022
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
13
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- Sugita AVM Microclip Applier
- K Number
- K221524
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4175
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mizuho America, Inc.
- Date Received
- May 26, 2022
- Decision Date
- June 24, 2022
- Product Code
- HCI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HCI | Applier, Aneurysm Clip | FDA class 2 | Neurology |
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Other Clearances by Mizuho America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211183 | Sugita AVM Microclips | Mar 2, 2022 | Substantially Equivalent |
| K990202 | SUGITA TITANIUM ANEURYSM CLIP | Jun 4, 1999 | Substantially Equivalent |
| K960037 | SUGITA AVM MICROCLIP | Feb 5, 1997 | Substantially Equivalent |
| K955012 | MIZUHO RADIOLUCENT HEAD FRAME | Sep 12, 1996 | Substantially Equivalent |