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510(k) K973558

VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) by Ultracell Medical Technologies, Inc. — Product Code FEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1997
Date Received
September 19, 1997
Clearance Type
Traditional
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 Ultracell Medical Technologies, Inc.

  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K972633 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K973083 — ULTRACELL NEURO SPONGES (December 9, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K970328 — ULTRACELL NEURO SPONGES (April 21, 1997)
  • K950647 — ULTRACELL NEURO SPONGES (August 15, 1995)
  • K950370 — ULTRACELL ORTHOPEDIC SPONGES (April 17, 1995)
  • K950373 — ULTRACELL ORTHOPEDIC SPONGES (April 17, 1995)

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  • K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid (January 14, 2022)
  • 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)