Cleared Traditional

K982557 - BARD PROFORMA AND APOLLO PRE-CURVED PAP...

K982557 is an FDA 510(k) clearance for BARD PROFORMA AND APOLLO PRE-CURVED PAP..., manufactured by Bard Interventional Products Div.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K982557 · Bard Interventional Products Div. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
50d
Days
Class 2
Risk

K982557 is an FDA 510(k) clearance for the BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Bard Interventional Products Div. (Billerica, US). The FDA issued a Cleared decision on September 10, 1998 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Bard Interventional Products Div. devices

FDA 510(k) Submission Details - K982557

510(k) Number K982557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1998
Decision Date September 10, 1998
Days to Decision 50 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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K982557.
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
K990850 · CooperSurgical, Inc. · Jun 1999
COOPERSURGICAL INFRARED COAGULATOR FOR ENT
K990855 · CooperSurgical, Inc. · Mar 1999
WILSON-COOK BIPOLAR PROBE
K990145 · Wilson-Cook Medical, Inc. · Mar 1999
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
K982289 · Olympus America, Inc. · Aug 1998
SPHINCTEROTOME
K973826 · Boston Scientific Corp · Dec 1997
WILSON-COOK NEEDLE KNIFE PAPILLOTOME
K972674 · Wilson-Cook Medical, Inc. · Aug 1997