Cleared Traditional

K851364 - FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PR...

K851364 is the FDA 510(k) clearance for FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PR... by Precision Dynamics Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K851364 · Precision Dynamics Corp. · Gastroenterology & Urology device
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Apr 1985
Decision
18d
Days
Class 2
Risk

K851364 is an FDA 510(k) clearance for the FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Precision Dynamics Corp. (Burbank, US). The FDA issued a Cleared decision on April 22, 1985 after a review of 18 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 Precision Dynamics Corp. devices

Submission Details

510(k) Number K851364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1985
Decision Date April 22, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 130d · This submission: 18d
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 162
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K851364.
MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY
K854291 · Medsurg Industries, Inc. · Nov 1985
MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM
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53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN
K851798 · Artiberia · May 1985
BONE BIOPSY SET
K820293 · The Anspach Effort, Inc. · Mar 1982
HEPAFIX BIOPSY NEEDLE SET
K813085 · Burron Medical Products, Inc. · Nov 1981
HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM
K781038 · Quinton, Inc. · Aug 1978