Cleared Traditional

K101832 - BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT

K101832 is an FDA 510(k) clearance for BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT, manufactured by Medical Device Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K101832 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Aug 2010
Decision
57d
Days
Class 2
Risk

K101832 is an FDA 510(k) clearance for the BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on August 27, 2010 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 Medical Device Technologies, Inc. devices

FDA 510(k) Submission Details - K101832

510(k) Number K101832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date August 27, 2010
Days to Decision 57 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
74d faster than avg
Panel avg: 131d · This submission: 57d
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 304
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