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510(k) K252624

KARL STORZ Laryngoscopes and Accessories by KARL STORZ Endoscopy-America, Inc. — Product Code EQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2026
Date Received
August 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Nasopharyngoscope
Device Class
Class II
Regulation Number
874.4760
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by KARL STORZ Endoscopy-America, Inc.

  • K223923 — HOPKINS Telescopes (March 30, 2023)
  • K202957 — Flexible Video Cysto-Urethroscope (C-view) (October 29, 2020)
  • 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)
  • K182696 — Telepack X LED (November 20, 2018)

Other clearances for product code EQN

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K834172 — OP-CON SURG. INSTRUMENT #7 (March 6, 1984)
  • K831255 — LARYNGOSCOPE ATTACHMENT PH2000 (September 12, 1983)
  • K830888 — COOL-LITE FIBERCOPTIC LARYNGEAL EXAM (April 27, 1983)
  • K822525 — LARYNGOSCOPES RIGID (September 9, 1982)
  • K821708 — NAGASHIMA LIGHT SOURCE UNIT SL-4 (June 25, 1982)
  • K821706 — NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL (June 25, 1982)
  • K821709 — NAGASHIMA LIGHT SOURCE UNIT SL-5 (June 25, 1982)
  • K821707 — NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT (June 25, 1982)