FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ASPACH 65,000 (MODIFICATION)
K Number: K955084
·
Decision Jan 17, 1996
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
55
Applicant Total
60
Review Days
90
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Basic Information
- Device Name
- ASPACH 65,000 (MODIFICATION)
- K Number
- K955084
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Anspach Effort, Inc.
- Date Received
- October 19, 1995
- Decision Date
- January 17, 1996
- Product Code
- HSZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| 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 |