Cleared Traditional

K953484 - POLLUX OA/POLLUX 30A/POLLUX 70A

K953484 is an FDA 510(k) clearance for POLLUX OA/POLLUX 30A/POLLUX 70A, manufactured by Pollux Endoscopy, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K953484 · Pollux Endoscopy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
38d
Days
Class 2
Risk

K953484 is an FDA 510(k) clearance for the POLLUX OA/POLLUX 30A/POLLUX 70A. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Pollux Endoscopy, Inc. (Sunrise, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 38 days - a notably fast clearance 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: 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 Pollux Endoscopy, Inc. devices

FDA 510(k) Submission Details - K953484

510(k) Number K953484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1995
Decision Date September 01, 1995
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
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 520
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K953484.
STRYKER PRESSURE SENSING CANNULA
K944593 · Stryker Endoscopy · Sep 1995
STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM
K951267 · Stryker Endoscopy · Sep 1995
UNIMAT PUMP
K953075 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
CO2 ARTHROFLATOR
K953550 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES
K950093 · Smith & Nephew Richards, Inc. · Aug 1995
INTEQ TFCC REPAIR SYSTEM
K941862 · Linvatec Corp. · Aug 1995