FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANSPAHC SPEED REDUCER
K Number: K960630
·
Decision Nov 19, 1996
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
26
Applicant Total
60
Review Days
284
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Basic Information
- Device Name
- ANSPAHC SPEED REDUCER
- K Number
- K960630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4370
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Anspach Effort, Inc.
- Date Received
- February 9, 1996
- Decision Date
- November 19, 1996
- Product Code
- HBB
- 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 |
|---|---|---|---|
| HBB | Motor, Drill, Pneumatic | FDA class 2 | Neurology |
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Other Clearances by The Anspach Effort, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | May 19, 2022 | Substantially Equivalent |
| K183545 | Anspach Helix Dissection Tools | Jul 19, 2019 | Substantially Equivalent |
| K180063 | OCM-G1 Attachment | Mar 27, 2018 | Substantially Equivalent |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | Jan 10, 2014 | Substantially Equivalent |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | Dec 31, 2013 | Substantially Equivalent |
| K113476 | ANSPACH DISSECTION TOOLS | Dec 16, 2011 | Substantially Equivalent |
| K082637 | CRANIAL PERFORATOR | Dec 22, 2008 | Substantially Equivalent |
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | Apr 30, 2008 | Substantially Equivalent |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | Jan 26, 2007 | Substantially Equivalent |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | Jan 16, 2007 | Substantially Equivalent |