FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
K Number: K924897
·
Decision Jul 6, 1993
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
46
Applicant Total
49
Review Days
280
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Basic Information
- Device Name
- XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
- K Number
- K924897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Devices, Inc.
- Date Received
- September 29, 1992
- Decision Date
- July 6, 1993
- Product Code
- GCT
- 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 |
|---|---|---|---|
| GCT | Light Source, Endoscope, Xenon Arc | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| 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 |
| 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 |
| K915694 | MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR | Jun 18, 1992 | Substantially Equivalent |