Cleared Traditional

K855176 - TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS

K855176 is an FDA 510(k) clearance for TRANSURETHAL PROSTATOME DIAG TREATM PRO..., manufactured by Urologic Surgical Devices Corp.. The device is a Class 2 Radiology device with product code FBK cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K855176 · Urologic Surgical Devices Corp. · Radiology device
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May 1986
Decision
138d
Days
Class 2
Risk

K855176 is an FDA 510(k) clearance for the TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Urologic Surgical Devices Corp. (Chicago, US). The FDA issued a Cleared decision on May 13, 1986 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.1500 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Urologic Surgical Devices Corp. devices

FDA 510(k) Submission Details - K855176

510(k) Number K855176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date May 13, 1986
Days to Decision 138 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 107d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBK Device Classification - Class 2, Special Controls

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 Radiology devices follow this clearance model.

Regulatory Peers - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 80
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K855176.
TRANSENDOSCOPIC ASPIRATION NEEDLE
K883093 · Endovations · Dec 1988
WASHING/INJECTION NEEDLE
K872060 · Endovations · Jul 1987
WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE
K865086 · Van-Tec, Inc. · Mar 1987
VARICES INJECTOR
K851952 · Wilson-Cook Medical, Inc. · Jul 1985
ENDOSCOPIC INJECTION NEEDLE
K820973 · Mill-Rose Laboratory · Apr 1982
VANCE CYSTOSCOPIC
K812057 · Vance Products, Inc. · Jul 1981