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510(k) K933354

HOBBS MEDICAL CLEANING BRUSH by Hobbs Medical, Inc. — Product Code FEB

K933354 is an FDA 510(k) premarket notification submitted by Hobbs Medical, Inc. for the device "HOBBS MEDICAL CLEANING BRUSH". The FDA issued a decision of Substantially Equivalent on October 28, 1993. The device falls under product code FEB (Accessories, Cleaning, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Hobbs Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1993
Date Received
July 9, 1993
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 Hobbs Medical, Inc.

  • K241874 — Aspiration Catheter (2189) (September 24, 2024)
  • K182927 — Pulmonary Cytology Brush (February 7, 2020)
  • K093079 — TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, (August 2, 2010)
  • K030765 — HOBBS MISTIFIER SPRAY CATHETER (June 9, 2003)
  • K922396 — FUJINON FORCEPS -- MODIFICATION (December 10, 1992)
  • K921026 — PRESSURE GAUGE (April 24, 1992)
  • K914358 — ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP (November 19, 1991)
  • K893729 — HOBBS MEDICAL MICROBIOLOGY BRUSH (August 28, 1989)
  • K872509 — LINDEN STONE EXTRACTION BALLOON (September 22, 1987)
  • K860593 — ET/RT PAPILLOTOME (July 22, 1986)

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)
  • 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)

FDA data resources