510(k) K182927

Pulmonary Cytology Brush by Hobbs Medical, Inc. — Product Code BTG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 7, 2020
Date Received: October 22, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Brush, Biopsy, Bronchoscope (Non-Rigid)
Device Class: Class II
Regulation Number: 874.4680
Review Panel: EN
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).

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K241874 — Aspiration Catheter (2189) (September 24, 2024)
K093079 — TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, (August 2, 2010)
K030765 — HOBBS MISTIFIER SPRAY CATHETER (June 9, 2003)
K933354 — HOBBS MEDICAL CLEANING BRUSH (October 28, 1993)
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)

510(k) K182927

Clearance Details

Device Classification

Other clearances by Hobbs Medical, Inc.

Other clearances for product code BTG