Cleared Traditional

K971838 - MICRO ELECTRODES

K971838 is an FDA 510(k) clearance for MICRO ELECTRODES, manufactured by CooperSurgical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K971838 · CooperSurgical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
170d
Days
Class 2
Risk

K971838 is an FDA 510(k) clearance for the MICRO ELECTRODES. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by CooperSurgical, Inc. (Shelton, US). The FDA issued a Cleared decision on November 5, 1997 after a review of 170 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all CooperSurgical, Inc. devices

FDA 510(k) Submission Details - K971838

510(k) Number K971838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1997
Decision Date November 05, 1997
Days to Decision 170 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 160d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNF Device Classification - Class 2, Special Controls

Product Code KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

All 34
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K971838.
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
K981464 · Omnitech Systems, Inc. · Jul 1998
VAPORIZATION ELECTRODES
K970961 · Richard Wolf Medical Instruments Corp. · Apr 1998
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS
K972856 · Rocket Medical Plc · Feb 1998
LAPARETTE
K971146 · Rd Chus, Inc. · Aug 1997
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)
K964594 · Circon Corp. · Aug 1997
RESISTICK SOLID LAPAROSCOPIC ELECTRODES
K971621 · Aaron Medical Industries · Jun 1997