FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DELICOT
K Number: K121822
·
Decision Sep 10, 2012
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
2
Review Days
81
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Basic Information
- Device Name
- DELICOT
- K Number
- K121822
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4700
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Surgical Company, LLC
- Date Received
- June 21, 2012
- Decision Date
- September 10, 2012
- Product Code
- HBA
- 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 |
|---|---|---|---|
| HBA | Neurosurgical Paddie | FDA class 2 | Neurology |
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Other Clearances by American Surgical Company, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K112598 | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) | Jun 20, 2013 | Substantially Equivalent |