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510(k) K915816

BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY by Gi Supply — Product Code EOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1992
Date Received
December 30, 1991
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 Gi Supply

  • K221042 — Renova RP Centesis Pump (April 19, 2023)
  • K202376 — EverLift Submucosal Lifting Agent (September 30, 2020)
  • K191923 — EverLift Submucosal Lifting Agent (June 20, 2020)
  • K031360 — GI SUPPLY BILIARY STENT (September 24, 2003)
  • K012411 — HP-ONE (September 25, 2001)
  • K970186 — GI SUPPLY PARACENTESIS PUMP (February 14, 1997)
  • K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT (February 14, 1997)
  • K944903 — HP-FAST (April 20, 1995)
  • K931044 — OXY-BLOC (October 4, 1993)

Other clearances for product code EOQ

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  • K251731 — KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (December 5, 2025)
  • K252045 — Ion Endoluminal System (IF1000) (September 23, 2025)
  • K251894 — Himaging Bronchscope System (September 23, 2025)
  • K252528 — Ion Endoluminal System (IF1000) (September 5, 2025)
  • K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (August 27, 2025)
  • 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)