Cleared Traditional

CYTOLOGY BRUSH (K780872) - FDA 510(k) Clearance

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K780872 · CooperVision, Inc. · Pathology device
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Sep 1978
Decision
100d
Days
Class 2
Risk

K780872 is an FDA 510(k) clearance for the CYTOLOGY BRUSH. Classified as Brush, Biopsy, Bronchoscope (non-rigid) (product code BTG), Class II - Special Controls.

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on September 7, 1978 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 874.4680 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all CooperVision, Inc. devices

Submission Details

510(k) Number K780872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1978
Decision Date September 07, 1978
Days to Decision 100 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 77d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTG Brush, Biopsy, Bronchoscope (non-rigid)
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.