Cleared Traditional

K780872 - CYTOLOGY BRUSH

K780872 is an FDA 510(k) clearance for CYTOLOGY BRUSH, manufactured by CooperVision, Inc.. The device is a Class 2 Pathology device with product code BTG cleared through the Traditional 510(k) pathway after a 100-day FDA review.

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

FDA 510(k) Submission Details - K780872

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
Combination Product No
PCCP Authorized No
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.

BTG Device Classification - Class 2, Special Controls

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.