FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIBLE FIBER OPTIC ENDOSCOPE
K Number: K922826
·
Decision Feb 19, 1993
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
9
Applicant Total
15
Review Days
253
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Basic Information
- Device Name
- FLEXIBLE FIBER OPTIC ENDOSCOPE
- K Number
- K922826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optimed Technologies, Inc.
- Date Received
- June 11, 1992
- Decision Date
- February 19, 1993
- Product Code
- FGA
- 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 |
|---|---|---|---|
| FGA | Kit, Nephroscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGA), ordered by most recent decision date.
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GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
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NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20
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FDA Class 2
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KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
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FDA Class 2
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Other Clearances by Optimed Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972520 | OPTIVIEW | Sep 29, 1997 | Substantially Equivalent |
| K955275 | BOOSTER TROPHY 5 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955276 | BOOSTER LITE 4 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955274 | BOOSTER LITE 3 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K943598 | FLEXIBLE FIBER OPTIC LAPAROSCOPES | Oct 18, 1994 | Substantially Equivalent |
| K926597 | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | Jul 12, 1994 | Substantially Equivalent |
| K921942 | HYSTEROSCOPE (AND ACCESSORIES) | Jun 24, 1994 | Substantially Equivalent |
| K922711 | FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE | May 17, 1994 | Substantially Equivalent |
| K921985 | ARTHROSCOPE & ACCESSORIES | Jun 29, 1993 | Substantially Equivalent |
| K921883 | ENDOSCOPE | Nov 23, 1992 | Substantially Equivalent |