Cleared Traditional

K984304 - RIWO DRIVE GENERATOR

K984304 is an FDA 510(k) clearance for RIWO DRIVE GENERATOR, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K984304 · Richard Wolf Medical Instruments Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
253d
Days
Class 2
Risk

K984304 is an FDA 510(k) clearance for the RIWO DRIVE GENERATOR. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 253 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K984304

510(k) Number K984304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1998
Decision Date August 12, 1999
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
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 521
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K984304.
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
K992876 · Mitek Products · Sep 1999
ARTHROSCOPE / MEDIFIX INC.
K992474 · Medifix, Inc. · Sep 1999
ENDOSCOPIC SPINAL ACCESS SYSTEM
K991794 · Endius, Inc. · Aug 1999
FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
K992040 · Fiber Imaging Technologies, Inc. · Aug 1999
E9000 SYSTEM
K990524 · Linvatec Corp. · Jul 1999
MTP ARTHROPUMP DISPOSABLE TUBING SET
K990911 · Mtp Medical Technical Promotion GmbH · Jun 1999