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510(k) K182696

Telepack X LED by KARL STORZ Endoscopy-America, Inc. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2018
Date Received
September 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Other clearances by KARL STORZ Endoscopy-America, Inc.

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  • K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver (October 22, 2020)
  • K201135 — Image1 S CCU, Image1 S 4U Camera Head (September 1, 2020)
  • K200740 — HD Video Rhino Laryngoscope (August 11, 2020)
  • K191357 — Flexible HD Cysto-Urethroscope System (September 18, 2019)
  • K182723 — Flexible HD Cysto-Urethroscope System (April 23, 2019)
  • K182186 — CMOS Video-Rhino-Laryngoscope System (March 22, 2019)
  • K183264 — Flex-THOR scope (January 18, 2019)
  • K180977 — KARL STORZ New Generation Trocars (July 18, 2018)

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  • K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F) (February 7, 2025)
  • K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (October 22, 2024)
  • K241371 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (July 3, 2024)
  • K222584 — EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100D (April 26, 2023)
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