Cleared Traditional

K930084 - MICRO-ARTHROSCOPE

K930084 is an FDA 510(k) clearance for MICRO-ARTHROSCOPE, manufactured by Medical Devices, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 967-day FDA review.

K930084 · Medical Devices, Inc. · Orthopedic device
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Sep 1995
Decision
967d
Days
Class 2
Risk

K930084 is an FDA 510(k) clearance for the MICRO-ARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Medical Devices, Inc. (Hackensack, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 967 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Medical Devices, Inc. devices

FDA 510(k) Submission Details - K930084

510(k) Number K930084 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 07, 1993
Decision Date September 01, 1995
Days to Decision 967 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
845d slower than avg
Panel avg: 122d · This submission: 967d
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 393
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K930084.
ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODIFICATION)
K953659 · Arthrocare Corp. · Sep 1995
GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH
K953868 · Richard Wolf Medical Instruments Corp. · Sep 1995
PRESSURE SENSING SCOPE SHEATH SYSTEM
K944553 · Linvatec Corp. · Sep 1995
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