FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYSTAL VISION AND ACCESSORIES
K Number: K932230
·
Decision Feb 18, 1994
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
16
Review Days
287
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Basic Information
- Device Name
- CRYSTAL VISION AND ACCESSORIES
- K Number
- K932230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- I.C Medical, Inc.
- Date Received
- May 7, 1993
- Decision Date
- February 18, 1994
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by I.C Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K960492 | SI CONTROLLER MODEL SI 500 | Dec 23, 1996 | 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 |
| K930098 | SPECULUM SMOKE EVACUATOR TUBING | Jul 28, 1993 | Substantially Equivalent |