Cleared Traditional

K012864 - INTERJECT INJECTION THERAPY NEEDLE

K012864 is the FDA 510(k) clearance for INTERJECT INJECTION THERAPY NEEDLE by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K012864 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
58d
Days
Class 2
Risk

K012864 is an FDA 510(k) clearance for the INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821.... Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on October 24, 2001 after a review of 58 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 Boston Scientific Corp devices

Submission Details

510(k) Number K012864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2001
Decision Date October 24, 2001
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 130d · This submission: 58d
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 49
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K012864.
EASY CORE BIOPSY SYSTEM II
K050120 · Boston Scientific Corp · Feb 2005
EASY CORE BIOPSY SYSTEM
K040893 · Boston Scientific Corp · May 2004
MODIFICATION TO TEMNO BIOPSY NEEDLES
K024120 · Allegiance Healthcare Corp. · Jan 2003
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · Wilson-Cook Medical, Inc. · Oct 2001
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · Olympus America, Inc. · Nov 1999
MRI NEEDLES
K963565 · Cook, Inc. · Jul 1997