FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEURO-SORB PATTIES
K Number: K770894
·
Decision Jun 20, 1977
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
10
Review Days
35
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Basic Information
- Device Name
- NEURO-SORB PATTIES
- K Number
- K770894
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4700
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Instranetics, Inc.
- Date Received
- May 16, 1977
- Decision Date
- June 20, 1977
- 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 |
Similar 510(k) Clearances
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AESCULAP NEURO PATTIES
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Other Clearances by Instranetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823430 | INSTRA-SAFE | Jan 7, 1983 | Substantially Equivalent |
| K811824 | CAUTERY CADDY PAD | Jul 20, 1981 | Substantially Equivalent |
| K811823 | SHARPS CADDY FB | Jul 20, 1981 | Substantially Equivalent |
| K811822 | TIP-VU | Jul 20, 1981 | Substantially Equivalent |
| K810294 | LINE CADDY | Feb 26, 1981 | Substantially Equivalent |
| K810208 | BLADE SAFE | Feb 12, 1981 | Substantially Equivalent |
| K802865 | SAFE T COUNT | Dec 18, 1980 | Substantially Equivalent |
| K802866 | SHARPS CADDY MAGNETIC & SHARPS CADDY FOA | Nov 17, 1980 | Substantially Equivalent |
| K781575 | DISPOSABLE LYMPHANGIOGRAM SET | Dec 4, 1978 | Substantially Equivalent |