FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Optimos Cystotome
K Number: K223256
·
Decision Apr 5, 2023
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
16
Review Days
166
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Basic Information
- Device Name
- Optimos Cystotome
- K Number
- K223256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taewoong Medical Co., Ltd.
- Date Received
- October 21, 2022
- Decision Date
- April 5, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNS), ordered by most recent decision date.
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Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
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Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
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SureTome SW Sphincterotome with DomeTip
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Other Clearances by Taewoong Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260962 | Sphincterotome | May 21, 2026 | Substantially Equivalent |
| K252648 | Niti-S SPAXUS Stent | Mar 13, 2026 | Substantially Equivalent |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Dec 29, 2025 | Unknown |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Oct 30, 2025 | Substantially Equivalent |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Mar 31, 2025 | Substantially Equivalent |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Jun 14, 2023 | Substantially Equivalent |
| K223626 | Niti-S Biliary Speed D Stent | May 26, 2023 | Unknown |
| K221482 | Esophageal TTS Stent | Jun 22, 2022 | Substantially Equivalent |
| K221071 | Niti-S Biliary Slim M Stent | Jun 9, 2022 | Unknown |
| K211706 | Esophageal TTS Stent | Oct 8, 2021 | Substantially Equivalent |