FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
K Number: K970937
·
Decision Sep 26, 1997
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
8
Review Days
197
Basic Information
- Device Name
- MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
- K Number
- K970937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MIST, INC.
- Date Received
- March 13, 1997
- Decision Date
- September 26, 1997
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
Disposable Trocars
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8 mm Assist Cannula; 12 mm Assist Cannula
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Boehringer Laboratories Liver Retractor
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Medical Monitor (32HS710S)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arthrex Synergy Vision Endoscopic Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LAGIS Suction Irrigation System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by MIST, INC.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K952323 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES | Jun 23, 1995 | Substantially Equivalent |
| K951648 | MIST ENDOSCOPIC NEEDLES | May 12, 1995 | Substantially Equivalent |
| K951480 | MIST TROCARS | May 3, 1995 | Substantially Equivalent |
| K951692 | MIST ENDOSCOPIC PROBES | May 3, 1995 | Substantially Equivalent |
| K951481 | MIST ENDOSCOPIC CANNULAS | May 3, 1995 | Substantially Equivalent |