Cleared Traditional

K990935 - JACKSON ESOPHAGEAL DILATOR

K990935 is an FDA 510(k) clearance for JACKSON ESOPHAGEAL DILATOR, manufactured by Pilling Weck Surgical. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K990935 · Pilling Weck Surgical · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
59d
Days
Class 2
Risk

K990935 is an FDA 510(k) clearance for the JACKSON ESOPHAGEAL DILATOR. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Pilling Weck Surgical (Fort Washington, US). The FDA issued a Cleared decision on May 17, 1999 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - 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 Pilling Weck Surgical devices

FDA 510(k) Submission Details - K990935

510(k) Number K990935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1999
Decision Date May 17, 1999
Days to Decision 59 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
72d faster than avg
Panel avg: 131d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNQ Device Classification - Class 2, Special Controls

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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 - KNQ Dilator, Esophageal

All 27
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K990935.
MEDOVATIONS ESOPHAGEAL DILATOR
K002363 · Medovations, Inc. · Nov 2000
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720 · Cordis Corp. · Jan 2000
IMPACT BALLOON DILATION CATHETER
K983373 · B. Braun/Mcgaw · Jun 1999
CRE(TM) BALLOON DILATATION CATHETER
K974788 · Boston Scientific Corp · Mar 1998
CRE BALLOON DILATATION CATHETER
K971320 · Boston Scientific Corp · Oct 1997
PATTISON ESOPHAGEAL DILATOR
K971615 · Tri-Med Specialties, Inc. · Jul 1997