Cleared Traditional

K960194 - MYELOTEC MYELOSCOPE

K960194 is an FDA 510(k) clearance for MYELOTEC MYELOSCOPE, manufactured by Myelotec, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K960194 · Myelotec, Inc. · Orthopedic device
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Sep 1996
Decision
232d
Days
Class 2
Risk

K960194 is an FDA 510(k) clearance for the MYELOTEC MYELOSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Myelotec, Inc. (Great Neck,, US). The FDA issued a Cleared decision on September 4, 1996 after a review of 232 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 Myelotec, Inc. devices

FDA 510(k) Submission Details - K960194

510(k) Number K960194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date September 04, 1996
Days to Decision 232 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 122d · This submission: 232d
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 K960194.
KARL STORZ MAGNIFYING ARTHROSOCPES
K961228 · KARL STORZ Endoscopy-America, Inc. · Oct 1996
APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET
K961590 · Linvatec Corp. · Oct 1996
AMO ARTHOSCOPES
K962330 · American Microptiks, Inc. · Sep 1996
ARTHRO-SURGIMAT
K962114 · W.O.M. World of Medicine GmbH · Aug 1996
ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K962321 · Arthrocare Corp. · Jul 1996
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)
K961747 · Arthrocare Corp. · Jul 1996