FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SI CONTROLLER MODEL SI 500
K Number: K960492
·
Decision Dec 23, 1996
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
16
Review Days
325
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Basic Information
- Device Name
- SI CONTROLLER MODEL SI 500
- K Number
- K960492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- I.C Medical, Inc.
- Date Received
- February 2, 1996
- Decision Date
- December 23, 1996
- Product Code
- BTA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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Other Clearances by I.C Medical, Inc.
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|---|---|---|---|
| K163659 | Crystal Vision | Oct 30, 2017 | Substantially Equivalent |
| K160160 | Non-Telescopic PenEvac | Apr 5, 2016 | Substantially Equivalent |
| K003840 | CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES | Feb 1, 2001 | Substantially Equivalent |
| K961616 | TELESCOPING PENEVAC (MODIFICATION) | May 28, 1996 | Substantially Equivalent |
| K955166 | PENEVAC SI. | Apr 11, 1996 | Substantially Equivalent |
| K955020 | PENEVAC ABC HANDPIECE | Apr 9, 1996 | Substantially Equivalent |
| K953418 | ELECTROCAUTERY SHROUD | Oct 7, 1995 | Substantially Equivalent |
| K954088 | TELESCOPING PENEVAC | Sep 22, 1995 | Substantially Equivalent |
| K932230 | CRYSTAL VISION AND ACCESSORIES | Feb 18, 1994 | Substantially Equivalent |
| K930098 | SPECULUM SMOKE EVACUATOR TUBING | Jul 28, 1993 | Substantially Equivalent |