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510(k) K831240

LASER BRONCHOSCOPE by Eder Instrument Co, Inc. — Product Code EOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1983
Date Received
April 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bronchoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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 Eder Instrument Co, Inc.

  • K843498 — BIPOLAR SUCTION ELECTRODE (December 14, 1984)
  • K843499 — ARTHROSCOPY LEG HOLDER (October 31, 1984)
  • K843497 — SURGICAL KNIVES & PROBES (October 31, 1984)
  • K831255 — LARYNGOSCOPE ATTACHMENT PH2000 (September 12, 1983)
  • K831241 — LASER LAPARAXOPE (June 10, 1983)
  • K822959 — ENDOSCOPIC VIDEOSYSTEM (October 22, 1982)
  • K802479 — SURGICAL KNIVES & PROBES (October 31, 1980)
  • K792100 — GRASPING FORCEP (W/FOUR PRONGS) (November 13, 1979)
  • K791052 — ENDOSCOPIC INSTRUMENT (August 3, 1979)

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  • K251823 — UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchosco (August 11, 2025)
  • K250232 — Vathin® Video Bronchoscope System (July 25, 2025)
  • K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEO (June 23, 2025)
  • K244017 — FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (June 13, 2025)