Cleared Traditional

K954882 - RIZA-RIBE NEEDLE (MODIFICATION)

K954882 is an FDA 510(k) clearance for RIZA-RIBE NEEDLE (MODIFICATION), manufactured by R-Med, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K954882 · R-Med, Inc. · Orthopedic device
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Nov 1995
Decision
98d
Days
Class 2
Risk

K954882 is an FDA 510(k) clearance for the RIZA-RIBE NEEDLE (MODIFICATION). Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by R-Med, Inc. (Oregon, US). The FDA issued a Cleared decision on November 16, 1995 after a review of 98 days - within the typical 510(k) review window.

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 R-Med, Inc. devices

FDA 510(k) Submission Details - K954882

510(k) Number K954882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1995
Decision Date November 16, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
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 394
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K954882.
KARL STORZ HEMPFLING DILATION SET
K954981 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY
K955272 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
INCLUSICE II(TM) ENDOSCOPE
K946087 · Sofamor Danek USA,Inc. · Nov 1995
RETROGRADE KNIFE
K954507 · Phx Technologies Corp. · Nov 1995
RETRACTOR
K954508 · Phx Technologies Corp. · Nov 1995
PROBE KNIFE
K954509 · Phx Technologies Corp. · Nov 1995