FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K Number: K112598
·
Decision Jun 20, 2013
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
2
Review Days
652
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Basic Information
- Device Name
- AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
- K Number
- K112598
- 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
- September 7, 2011
- Decision Date
- June 20, 2013
- 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 | ||
|---|---|---|---|
| K121822 | DELICOT | Sep 10, 2012 | Substantially Equivalent |