FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KSEA FIBERSCOPE
K Number: K011793
·
Decision Apr 17, 2002
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
40
Applicant Total
334
Review Days
313
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Basic Information
- Device Name
- KSEA FIBERSCOPE
- K Number
- K011793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date Received
- June 8, 2001
- Decision Date
- April 17, 2002
- Product Code
- LYK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LYK | Angioscope | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by KARL STORZ Endoscopy-America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and Accessories | May 15, 2026 | Substantially Equivalent |
| K223923 | HOPKINS Telescopes | Mar 30, 2023 | Substantially Equivalent |
| K202957 | Flexible Video Cysto-Urethroscope (C-view) | Oct 29, 2020 | Substantially Equivalent |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | Oct 22, 2020 | Substantially Equivalent |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | Sep 1, 2020 | Substantially Equivalent |
| K200740 | HD Video Rhino Laryngoscope | Aug 11, 2020 | Substantially Equivalent |
| K191357 | Flexible HD Cysto-Urethroscope System | Sep 18, 2019 | Substantially Equivalent |
| K182723 | Flexible HD Cysto-Urethroscope System | Apr 23, 2019 | Substantially Equivalent |
| K182186 | CMOS Video-Rhino-Laryngoscope System | Mar 22, 2019 | Substantially Equivalent |
| K183264 | Flex-THOR scope | Jan 18, 2019 | Substantially Equivalent |