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510(k) K914442

COX DISPOSABLE ENDOSCOPE CLEANING BRUSH by Cox Medical Ent., Inc. — Product Code FEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1991
Date Received
October 4, 1991
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 Cox Medical Ent., Inc.

  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)
  • K950689 — UCB (March 6, 1995)
  • K941464 — BASICS ENDOSCOPY SYSTEM (August 5, 1994)
  • K940911 — BASICS ENDOSCOPY SYSTEM (May 16, 1994)
  • K932790 — THERMAL OPTION (January 28, 1994)
  • K935250 — ACCU-PATH (January 21, 1994)
  • K924655 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) (December 15, 1992)
  • K923671 — COX DISPOSABLE POLYPECTOMY SNARES (October 13, 1992)
  • K923672 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (September 23, 1992)
  • K923489 — COX DISPOSABLE RETRIEVAL DEVICES (September 23, 1992)

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  • K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (April 23, 2019)
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  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)