Cleared Traditional

K935617 - ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION

K935617 is an FDA 510(k) clearance for ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION, manufactured by Davol Inc., Sub. C. R. Bard, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K935617 · Davol Inc., Sub. C. R. Bard, Inc. · Orthopedic device
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Sep 1994
Decision
298d
Days
Class 2
Risk

K935617 is an FDA 510(k) clearance for the ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Davol Inc., Sub. C. R. Bard, Inc. (Cranston, US). The FDA issued a Cleared decision on September 16, 1994 after a review of 298 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 Davol Inc., Sub. C. R. Bard, Inc. devices

FDA 510(k) Submission Details - K935617

510(k) Number K935617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1993
Decision Date September 16, 1994
Days to Decision 298 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
176d slower than avg
Panel avg: 122d · This submission: 298d
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 414
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K935617.
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