Cleared Traditional

K983569 - KSEA MONOPOLAR VAPORIZATION ELECTRODES

K983569 is an FDA 510(k) clearance for KSEA MONOPOLAR VAPORIZATION ELECTRODES, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K983569 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
87d
Days
Class 2
Risk

K983569 is an FDA 510(k) clearance for the KSEA MONOPOLAR VAPORIZATION ELECTRODES. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on January 8, 1999 after a review of 87 days - a notably fast clearance cycle.

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: 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K983569

510(k) Number K983569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date January 08, 1999
Days to Decision 87 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
73d faster than avg
Panel avg: 160d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIH Device Classification - Class 2, Special Controls

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 144
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K983569.
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K982738 · Gynecare, Inc. · Mar 1999
KSEA HF-SNARE
K983901 · KARL STORZ Endoscopy-America, Inc. · Feb 1999
GYRUS HYSTEROSCOPIC RESECTOSCOPE
K982771 · Gyrus Medical , Ltd. · Jan 1999
MEDIVISION HYSTEROSCOPE
K982659 · Medivision Scope Service Center, Inc. · Oct 1998
WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES
K980302 · Richard Wolf Medical Instruments Corp. · Jul 1998
GALILEO DISPOSABLE HYSTEROSCOPES
K981828 · Netoptix Corp. · Jul 1998