Cleared Traditional

K911974 - PGK STEREOTACTIC DEVICE

K911974 is an FDA 510(k) clearance for PGK STEREOTACTIC DEVICE, manufactured by Northern Virginia Radiology and Nuclear Medicine. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K911974 · Northern Virginia Radiology and Nuclear Medicine · Orthopedic device
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Nov 1991
Decision
186d
Days
Class 2
Risk

K911974 is an FDA 510(k) clearance for the PGK STEREOTACTIC DEVICE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Northern Virginia Radiology and Nuclear Medicine (Falls Church, US). The FDA issued a Cleared decision on November 5, 1991 after a review of 186 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.

FDA 510(k) Submission Details - K911974

510(k) Number K911974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1991
Decision Date November 05, 1991
Days to Decision 186 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 122d · This submission: 186d
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 628
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K911974.
SMALL JOINT SYSTEM
K914559 · Smith & Nephew Dyonics, Inc. · Feb 1992
DANEK SPINALSCOPE
K901692 · Danek Medical, Inc. · Feb 1992
3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA
K912099 · 3M Company · Dec 1991
ARTHRO-FLOW IRRIGATION 2 SYSTEM
K913028 · Davol, Inc. · Oct 1991
CONCEPT MICROMILL
K912957 · Concept, Inc. · Oct 1991
OPTICAL CATHETER ARTHROSCOPE
K911296 · Medical Dynamics, Inc. · Sep 1991