Cleared Traditional

K930191 - DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY

K930191 is an FDA 510(k) clearance for DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY, manufactured by Sofamor Danek Mfg., Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 985-day FDA review.

K930191 · Sofamor Danek Mfg., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
985d
Days
Class 2
Risk

K930191 is an FDA 510(k) clearance for the DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on September 26, 1995 after a review of 985 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 Sofamor Danek Mfg., Inc. devices

FDA 510(k) Submission Details - K930191

510(k) Number K930191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date September 26, 1995
Days to Decision 985 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
863d slower than avg
Panel avg: 122d · This submission: 985d
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 413
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K930191.
PROBE
K954476 · Phx Technologies Corp. · Oct 1995
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
DISPOSABLE BIOPSY FORCEP
K952630 · Neuro Navigational Corp. · Sep 1995
DISPOSABLE TOOTHED GRASPING FORCEP
K952639 · Neuro Navigational Corp. · Sep 1995