Cleared Traditional

K130616 - MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES (FDA 510(k) Clearance)

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

K130616 · Biopsybell S.R.L. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
337d
Days
Class 2
Risk

K130616 is an FDA 510(k) clearance for the MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-B.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Biopsybell S.R.L. (Verona, US). The FDA issued a Cleared decision on February 7, 2014 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biopsybell S.R.L. devices

Submission Details

510(k) Number K130616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date February 07, 2014
Days to Decision 337 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
207d slower than avg
Panel avg: 130d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 359
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