Cleared Traditional

K962538 - BARD COAGULATING RESECTOR MODEL (3552XX

Also marketed or referenced as:
XX=01,02,03,04,05 OR 06)

K962538 is the FDA 510(k) clearance for BARD COAGULATING RESECTOR MODEL (3552XX by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAS) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K962538 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
172d
Days
Class 2
Risk

K962538 is an FDA 510(k) clearance for the BARD COAGULATING RESECTOR MODEL (3552XX. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on December 17, 1996 after a review of 172 days - an extended review 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: 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K962538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1996
Decision Date December 17, 1996
Days to Decision 172 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
42d slower than avg
Panel avg: 130d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAS Electrode, Electrosurgical, Active, Urological
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 - FAS Electrode, Electrosurgical, Active, Urological

All 27
Devices cleared under the same product code (FAS) and FDA review panel - the closest regulatory comparables to K962538.
AMS COAGULOOP RESECTION ELECTRODE
K971512 · American Medical Systems, Inc. · Jul 1997
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
K970526 · Arthrocare Corp. · May 1997
VAPOR-TECH SLED ELECTRODE
K970717 · Northgate Technologies, Inc. · May 1997
BARD V-MAX ROLLER BAR (3551XX
K961841 · C.R. Bard, Inc. · Oct 1996
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
K953983 · Richard Wolf Medical Instruments Corp. · Oct 1996
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
K961069 · Arthrocare Corp. · May 1996