HOBBS MEDICAL MICROBIOLOGY BRUSH— 510(k) K893729

Clearance details

Applicant

Hobbs Medical, Inc.

Product code

Code FDX

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

1989-05-17

Decision date

1989-08-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stafford Springs, CT, US

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• Z-0711-2022 — Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.Class II·Ongoing·Hobbs Medical, Inc.·20211228

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K893729.