Cleared Traditional

K011270 - AUTOMATED CORE BIOPSY DEVICE (FDA 510(k) Clearance)

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

K011270 · Promex, Inc. · Gastroenterology & Urology device
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Jun 2001
Decision
57d
Days
Class 2
Risk

K011270 is an FDA 510(k) clearance for the AUTOMATED CORE BIOPSY DEVICE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Promex, Inc. (Franklin, US). The FDA issued a Cleared decision on June 22, 2001 after a review of 57 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 Promex, Inc. devices

Submission Details

510(k) Number K011270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2001
Decision Date June 22, 2001
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
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 K011270.
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
K252646 · Olympus Medical Systems Corp. · Oct 2025
ClearTip FNA and FNB Types
K250994 · Finemedix Co., Ltd. · Aug 2025
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
K241209 · Cook Ireland, Ltd. · Jul 2024
Precision GI
K231422 · Limaca Medical, Ltd. · Aug 2023
ClearTip
K231267 · Finemedix Co., Ltd. · Jun 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · Cook Ireland, Ltd. · May 2023