Telepack +
FDA 510(k) K221174 · Karl Storz Endoscopy America, Inc.
510(k) numberK221174
Submission
- Device name
- Telepack +
- Applicant
- Karl Storz Endoscopy America, Inc.
El Segundo, CA, US - Received
- April 25, 2022
- Decision date
- May 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
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|---|---|---|---|
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | Olympus Medical Systems Corp. | 09/10/2026SE |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET · Special | Fujifilm Corporation | 07/02/2026SE |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LBFET · Traditional | Olympus Medical Systems Corporation | 06/24/2026SE |
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| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K)FET · Traditional | Univlabs Technologies Private Limited | 08/11/2025SE |
| K250204 | Endoscopic Camera SystemFET · Traditional | Shenzhen Sophway Technology Co., Ltd. | 07/01/2025SE |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFET · Traditional | Fujifilm Corporation | 04/11/2025SE |
| K242067 | Visera Elite III Video System Center Olympus OTV-S700; Visera Elite III LED Light Source…FET · Traditional | Olympus Corporations of the Americas | 04/02/2025SE |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F)FET · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 02/07/2025SE |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)FET · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 10/22/2024SE |
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| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
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| K222504 | H1GCJ · Traditional | 11/10/2022SE |
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Questions and answers
When was Telepack + cleared by the FDA?
Telepack + (K221174) received a 510(k) decision of Substantially Equivalent on May 13, 2022, 18 days after the submission was received.
What is the product code of K221174?
The FDA product code is FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.