Cleared Traditional

K955471 - INCL ENDOSCOPE

K955471 is an FDA 510(k) clearance for INCL ENDOSCOPE, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K955471 · Sofamor Danek USA,Inc. · Orthopedic device
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Dec 1995
Decision
69d
Days
Class 2
Risk

K955471 is an FDA 510(k) clearance for the INCL ENDOSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on December 18, 1995 after a review of 69 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K955471

510(k) Number K955471 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 10, 1995
Decision Date December 18, 1995
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
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 K955471.
BOZOTTA REINSERTION FORCEPS
K955480 · KARL STORZ Endoscopy-America, Inc. · Feb 1996
VIDEOSCOPE W/IRRIGATION SHEATH
K954016 · T. Korossurgical Instruments Corp. · Jan 1996
KARL STORZ TARGETING UNIT
K955652 · KARL STORZ Endoscopy-America, Inc. · Jan 1996
CANNULOC THREADED CANNULA
K955273 · Linvatec Corp. · Dec 1995
DISCETOME TISSUE ASPIRATOR
K953998 · T. Korossurgical Instruments Corp. · Dec 1995
KARL STORZ HEMPFLING DILATION SET
K954981 · KARL STORZ Endoscopy-America, Inc. · Dec 1995