FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTRUMED RONGEUR
K Number: K081651
·
Decision Aug 8, 2008
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
35
Applicant Total
7
Review Days
57
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INSTRUMED RONGEUR
- K Number
- K081651
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4840
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumed International, Inc.
- Date Received
- June 12, 2008
- Decision Date
- August 8, 2008
- Product Code
- HAE
- 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 |
|---|---|---|---|
| HAE | Rongeur, Manual | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HAE), ordered by most recent decision date.
Geister K-Rex rongeurs
FDA 510(k)
FDA Class 2
·Neurology
SQ.line KERRISON
FDA 510(k)
FDA Class 2
·Neurology
Rebellion, Phantom Multi-Bite Kerrison Rongeur
FDA 510(k)
FDA Class 2
·Neurology
Rebellion; Phantom Multi-Bite Kerrison Rongeur
FDA 510(k)
FDA Class 2
·Neurology
KLS Martin Neuro Rongeurs
FDA 510(k)
FDA Class 2
·Neurology
Rebellion, Phantom Multi-Bite Kerrison Rongeur
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Instrumed International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | Aug 31, 2010 | Substantially Equivalent |
| K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | Apr 29, 2010 | Substantially Equivalent |
| K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | Dec 3, 2009 | Substantially Equivalent |
| K092544 | INSTRUMED VASCULAR CLAMPS | Oct 26, 2009 | Substantially Equivalent |
| K071771 | INSTRUMED RETRACTORS | Aug 2, 2007 | Substantially Equivalent |
| K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES | Apr 16, 2004 | Substantially Equivalent |