Cleared Traditional

K981828 - GALILEO DISPOSABLE HYSTEROSCOPES

K981828 is an FDA 510(k) clearance for GALILEO DISPOSABLE HYSTEROSCOPES, manufactured by Netoptix Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K981828 · Netoptix Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
46d
Days
Class 2
Risk

K981828 is an FDA 510(k) clearance for the GALILEO DISPOSABLE HYSTEROSCOPES. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Netoptix Corp. (North Attleboro, US). The FDA issued a Cleared decision on July 7, 1998 after a review of 46 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 Netoptix Corp. devices

FDA 510(k) Submission Details - K981828

510(k) Number K981828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date July 07, 1998
Days to Decision 46 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
114d faster than avg
Panel avg: 160d · This submission: 46d
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 132
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K981828.
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K983569 · KARL STORZ Endoscopy-America, Inc. · 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
SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606
K981800 · Equal Diagnostics, Inc. · Jul 1998
GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
K971374 · Wilson Greatbatch Technologies, Inc. · May 1998
GALILEO DISPOSABLE HYSTEROSCOPES
K974297 · Netoptix Corp. · Feb 1998