FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANSPACH INSTRUMENT CADDY
K Number: K801329
·
Decision Jun 9, 1980
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
55
Applicant Total
57
Review Days
6
Basic Information
- Device Name
- ANSPACH INSTRUMENT CADDY
- K Number
- K801329
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- THE ANSPACH EFFORT, INC.
- Date Received
- June 3, 1980
- Decision Date
- June 9, 1980
- 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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Other Clearances by THE ANSPACH EFFORT, INC.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K052572 | ANSPACH KNOTLESS ANCHOR | Dec 5, 2005 | Substantially Equivalent |
| K050628 | ANSPACH COUPLER | Apr 7, 2005 | Substantially Equivalent |
| K042783 | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM | Dec 17, 2004 | Substantially Equivalent |