Cleared Traditional

K936280 - GALILEO ARTHROSCOPES

K936280 is an FDA 510(k) clearance for GALILEO ARTHROSCOPES, manufactured by Galileo Electro-Optics Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K936280 · Galileo Electro-Optics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
284d
Days
Class 2
Risk

K936280 is an FDA 510(k) clearance for the GALILEO ARTHROSCOPES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Galileo Electro-Optics Corp. (Sturbridge, US). The FDA issued a Cleared decision on July 12, 1994 after a review of 284 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Galileo Electro-Optics Corp. devices

FDA 510(k) Submission Details - K936280

510(k) Number K936280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1993
Decision Date July 12, 1994
Days to Decision 284 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 122d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 394
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K936280.
INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER
K941273 · Innovasive Devices, Inc. · Sep 1994
REVO ROTATOR CUFF REPAIR SYSTEM
K941691 · Linvatec Corp. · Sep 1994
CARPAL TUNNEL SYSTEM
K940234 · Richard Wolf Medical Instruments Corp. · Aug 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · Smith & Nephew, Inc. · Jun 1994
ACUFEX DISPOSABLE MENISCAL CANNULA
K932090 · Acufex Microsurgical, Inc. · Jun 1994
ACUMED FLEXIBLE CANNULA
K932099 · Acu Med, Inc. · Jun 1994