Cleared Traditional

K962271 - ELECTROSURGICAL ELECRTRODES

K962271 is the FDA 510(k) clearance for ELECTROSURGICAL ELECRTRODES by Northgate Technologies, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 421-day FDA review.

K962271 · Northgate Technologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
421d
Days
Class 2
Risk

K962271 is an FDA 510(k) clearance for the ELECTROSURGICAL ELECRTRODES. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on August 8, 1997 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Northgate Technologies, Inc. devices

Submission Details

510(k) Number K962271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1996
Decision Date August 08, 1997
Days to Decision 421 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
261d slower than avg
Panel avg: 160d · This submission: 421d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
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 - HIH Hysteroscope (and Accessories)

All 107
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K962271.
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K983569 · KARL STORZ Endoscopy-America, Inc. · Jan 1999
WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES
K980302 · Richard Wolf Medical Instruments Corp. · Jul 1998
MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212)
K971420 · Richard Wolf Medical Instruments Corp. · Oct 1997
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES
K971518 · KARL STORZ Endoscopy-America, Inc. · Jul 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS
K971188 · Smith & Nephew, Inc. · Jun 1997
ROLLER ELECTRODE
K954488 · Olympus America, Inc. · Mar 1997