FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECULUM SMOKE EVACUATOR TUBING
K Number: K930098
·
Decision Jul 28, 1993
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
14
Review Days
201
Basic Information
- Device Name
- SPECULUM SMOKE EVACUATOR TUBING
- K Number
- K930098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- I.C. MEDICAL, INC.
- Date Received
- January 8, 1993
- Decision Date
- July 28, 1993
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by I.C. MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K932230 | CRYSTAL VISION AND ACCESSORIES | Feb 18, 1994 | Substantially Equivalent |
| K930099 | LASER HANDPIECE SHROUD | Jul 28, 1993 | Substantially Equivalent |
| K930097 | ELECTROCAUTERY SHROUD | Jul 28, 1993 | Substantially Equivalent |