FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Universal Light Handle Cover, Light Handle Cover
K Number: K150532
·
Decision Sep 22, 2015
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
25
Applicant Total
6
Review Days
204
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Basic Information
- Device Name
- Universal Light Handle Cover, Light Handle Cover
- K Number
- K150532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Key Surgical, Inc.
- Date Received
- March 2, 2015
- Decision Date
- September 22, 2015
- Product Code
- FTA
- 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 |
|---|---|---|---|
| FTA | Light, Surgical, Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Key Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151222 | Cautery Tip Cleaner | May 22, 2015 | Substantially Equivalent |
| K910328 | KEY COMFORT GRIPS | Mar 6, 1991 | Substantially Equivalent |
| K896676 | KEY VASCULAR LOOPS | Feb 27, 1990 | Substantially Equivalent |
| K896472 | KEY VASCULAR BOOTIES | Dec 14, 1989 | Substantially Equivalent |
| K895591 | SILICONE INSTRUMENT SHODS | Oct 20, 1989 | Substantially Equivalent |