FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES
K Number: K952323
·
Decision Jun 23, 1995
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
8
Review Days
36
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Basic Information
- Device Name
- MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES
- K Number
- K952323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mist, Inc.
- Date Received
- May 18, 1995
- Decision Date
- June 23, 1995
- Product Code
- JOS
- 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 |
|---|---|---|---|
| JOS | Electrode, Electrosurgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Mist, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970937 | MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) | Sep 26, 1997 | Substantially Equivalent |
| K971150 | MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE | Sep 23, 1997 | Substantially Equivalent |
| K952290 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES | Jun 23, 1995 | Substantially Equivalent |
| K951648 | MIST ENDOSCOPIC NEEDLES | May 12, 1995 | Substantially Equivalent |
| K951692 | MIST ENDOSCOPIC PROBES | May 3, 1995 | Substantially Equivalent |
| K951481 | MIST ENDOSCOPIC CANNULAS | May 3, 1995 | Substantially Equivalent |
| K951480 | MIST TROCARS | May 3, 1995 | Substantially Equivalent |