Cleared Traditional

K173316 - SpeedBird Model SB38 Soft Tissue Biopsy...

Also marketed or referenced as:
SpeedBird Model SBU Soft Tissue Biopsy Device SpeedBird Model SBU99 Soft Tissue Biopsy Device

K173316 is the FDA 510(k) clearance for SpeedBird Model SB38 Soft Tissue Biopsy... by Transmed7, LLC. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K173316 · Transmed7, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
243d
Days
Class 2
Risk

K173316 is an FDA 510(k) clearance for the SpeedBird Model SB38 Soft Tissue Biopsy Device. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Transmed7, LLC (Portola Valley, US). The FDA issued a Cleared decision on June 19, 2018 after a review of 243 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Transmed7, LLC devices

Submission Details

510(k) Number K173316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2017
Decision Date June 19, 2018
Days to Decision 243 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
113d slower than avg
Panel avg: 130d · This submission: 243d
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 160
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K173316.
Ranfac Cartilage Biopsy Needle
K183146 · Ranfac Corporation · Apr 2019
Medax Biopsy Systems III
K181803 · Medax Srl Unipersonale · Oct 2018
BEXCORE Breast Biopsy System, Biopsy Needle
K171890 · Medical Park Co., Ltd. · Aug 2018
Celling Aspiration Needle
K180807 · Spine Smith Holdings, LLC · May 2018
Eviva Stereotactic Guided Breast Biopsy System
K180233 · Hologic, Inc. · Apr 2018
Corvocet Biopsy System
K180450 · Merit Medical Systems, Inc. · Mar 2018