FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIPOLAR ENDOSTASIS PROBE, BEST (TM)
K Number: K915408
·
Decision Mar 11, 1992
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
49
Review Days
100
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Basic Information
- Device Name
- BIPOLAR ENDOSTASIS PROBE, BEST (TM)
- K Number
- K915408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Devices, Inc.
- Date Received
- December 2, 1991
- Decision Date
- March 11, 1992
- Product Code
- KNS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K930084 | MICRO-ARTHROSCOPE | Sep 1, 1995 | Substantially Equivalent for Some Indications |
| K943126 | ELECTROFLEX | Dec 5, 1994 | Substantially Equivalent |
| K940012 | SMARTBRACE ELECTRODE | Dec 5, 1994 | Substantially Equivalent |
| K935132 | HOME MICROCURRENT HMC | Mar 14, 1994 | Substantially Equivalent |
| K934619 | FLEXMATE | Feb 23, 1994 | Substantially Equivalent |
| K924897 | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 | Jul 6, 1993 | Substantially Equivalent |
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | May 17, 1993 | Substantially Equivalent |
| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | Jul 21, 1992 | Substantially Equivalent |