Cleared Traditional

K950982 - B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE (FDA 510(k) Clearance)

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

K950982 · B. Braun of America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
32d
Days
Class 2
Risk

K950982 is an FDA 510(k) clearance for the B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 4, 1995 after a review of 32 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B. Braun of America, Inc. devices

Submission Details

510(k) Number K950982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date April 04, 1995
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCG Biopsy Needle
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 - FCG Biopsy Needle

All 132
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K950982.
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K231267 · Finemedix Co., Ltd. · Jun 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · Cook Ireland, Ltd. · May 2023