Cleared Traditional

K981256 - ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE

K981256 is an FDA 510(k) clearance for ISOLATED SALINE ELECTRODES/PROBES/DEVIC..., manufactured by Ximed/Prosure/Injectx. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K981256 · Ximed/Prosure/Injectx · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 1998
Decision
40d
Days
Class 2
Risk

K981256 is an FDA 510(k) clearance for the ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Ximed/Prosure/Injectx (San Jose, US). The FDA issued a Cleared decision on May 12, 1998 after a review of 40 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 Ximed/Prosure/Injectx devices

FDA 510(k) Submission Details - K981256

510(k) Number K981256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date May 12, 1998
Days to Decision 40 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 131d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAS Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (FAS) and FDA review panel - the closest regulatory comparables to K981256.
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K022543 · Arthrocare Corp. · Aug 2002
COAGULOOP
K991314 · American Medical Systems, Inc. · Jun 1999
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
K973820 · Circon Corp. · May 1998
ELECTRODES/PROBES/DEVICES
K974637 · Ximed/Prosure/Injectx · Jan 1998
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
K974515 · Endolap, Inc. · Dec 1997
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
K974516 · Endolap, Inc. · Dec 1997