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510(k) K213833

SCOPE BUDDY PLUS Endoscope Flushing Aid by Medivators, Inc. — Product Code FEB

K213833 is an FDA 510(k) premarket notification submitted by Medivators, Inc. for the device "SCOPE BUDDY PLUS Endoscope Flushing Aid". The FDA issued a decision of Substantially Equivalent on January 14, 2022. The device falls under product code FEB (Accessories, Cleaning, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Medivators, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2022
Date Received
December 9, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Cleaning, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
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 Medivators, Inc.

  • K231418 — ENDOGATOR™ Hybrid Irrigation Tubing (August 14, 2023)
  • K223040 — Endo SmartCap (March 1, 2023)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)
  • K162128 — Scope Buddy Plus Endoscope Flushing Aid (December 21, 2016)
  • K160846 — AmplifEYE (July 14, 2016)
  • K152394 — Rapicide PA High-Level Disinfectant Test Strips (March 11, 2016)
  • K151522 — DEFENDO Bronchoscopy Suction Valve (September 17, 2015)
  • K133724 — MINNCARE HD (August 27, 2014)
  • K140753 — ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM (July 15, 2014)
  • K993042 — MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT (August 17, 2000)

Other clearances for product code FEB

  • K241168 — System 83 Revolve Endoscope Washer/Disinfector (December 19, 2024)
  • K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (December 2, 2024)
  • K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (June 30, 2023)
  • K201920 — Endoscope Reprocessor OER-Elite (September 1, 2020)
  • K173590 — System 83 Plus Washer/Disinfector (March 30, 2020)
  • K190969 — ENDOSCOPE REPROCESSOR OER-Elite (July 9, 2019)
  • K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (April 23, 2019)
  • K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System (December 14, 2018)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)
  • K162120 — Scope-Assist Flushing Sink (April 28, 2017)

FDA data resources