Pulmonary Cytology Brush— 510(k) K182927

Substantially Equivalent

Hobbs Medical, Inc.

FDA 510(k) clearance K182927 for Pulmonary Cytology Brush, Substantially Equivalent on 2020-02-07. Applicant: Hobbs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hobbs Medical, Inc.
Product code: Code BTG
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2018-10-22
Decision date: 2020-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stafford Springs, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTG

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K130357 — SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH2013-11-06
K820771 — MICROBIOLOGY SPECIMEN BRUSH1982-05-03
K780872 — CYTOLOGY BRUSH1978-09-07

More clearances from Hobbs Medical, Inc.

K241874 — Aspiration Catheter (2189)2024-09-24
K093079 — TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U2010-08-02
K030765 — HOBBS MISTIFIER SPRAY CATHETER2003-06-09
K933354 — HOBBS MEDICAL CLEANING BRUSH1993-10-28
K922396 — FUJINON FORCEPS -- MODIFICATION1992-12-10

Recalls naming K182927

K-number listed on FDA's recall record

Z-0013-2023 — Hobbs Medical Cytology Brush Catalog Number: 4204Class II·Ongoing·Hobbs Medical, Inc.·20220729
Z-0015-2023 — Hobbs Medical Polypectomy Snare Catalog Number: 4563Class II·Ongoing·Hobbs Medical, Inc.·20220729

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182927.

Data sourced from openFDA. This site is unofficial and independent of the FDA.