Cleared Traditional

K904987 - VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)

K904987 is an FDA 510(k) clearance for VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD), manufactured by Vibronics. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K904987 · Vibronics · Gastroenterology & Urology device
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Feb 1991
Decision
96d
Days
Class 2
Risk

K904987 is an FDA 510(k) clearance for the VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD). Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Vibronics (Danville, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vibronics devices

FDA 510(k) Submission Details - K904987

510(k) Number K904987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date February 11, 1991
Days to Decision 96 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 130d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K904987.
MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE
K914874 · Manan Medical Products, Inc. · Feb 1992
APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501
K913098 · Dlp, Inc. · Nov 1991
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
K910190 · C.R. Bard, Inc. · Aug 1991
MAXX 470 CORE BIOPSY GUN
K900082 · Dlp, Inc. · Jun 1990
MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES
K895457 · Advance Medical Designs, Inc. · Nov 1989
GASTRO ENTEROLOGICAL BIOPTOME
K894419 · Symbiosis Corp. · Sep 1989