Cleared Traditional

CYTOLOGY BRUSH

K780872 · CooperVision, Inc. · Pathology

Sep 1978

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K780872 is an FDA 510(k) clearance for the CYTOLOGY BRUSH, a Brush, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BTG), submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on September 7, 1978, 100 days after receiving the submission on May 30, 1978. This device falls under the Pathology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K780872 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 1978
Decision Date	September 07, 1978
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—

Device Classification

Product Code	BTG — Brush, Biopsy, Bronchoscope (non-rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	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).