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510(k) K193235

Telepack + by Karl Storz Endoscopy America, Inc. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2019
Date Received
November 25, 2019
Clearance Type
Special
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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  • K230359 — KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (3 (June 23, 2023)
  • K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable (March 17, 2023)
  • K221004 — HOPKINS Telescopes (December 20, 2022)
  • K222504 — H1 (November 10, 2022)
  • K213194 — HD Mediastinoscope (June 23, 2022)
  • K221174 — Telepack + (May 13, 2022)
  • K212458 — Flexible Video-Uretero-Renoscope SSU System (January 20, 2022)
  • K212656 — Flexible Intubation Video Endoscope – Sterile (FIVE-S) (December 29, 2021)

Other clearances for product code FET

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  • K250204 — Endoscopic Camera System (July 1, 2025)
  • K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (April 11, 2025)
  • K242067 — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGH (April 2, 2025)
  • 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)
  • K212808 — Logic Hd camera head green, System green (June 14, 2022)