Cleared Traditional

K982133 - OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA...

K982133 is an FDA 510(k) clearance for OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA..., manufactured by The Olympus Optical Co.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K982133 · The Olympus Optical Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
127d
Days
Class 2
Risk

K982133 is an FDA 510(k) clearance for the OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by The Olympus Optical Co. (North Attleboro, US). The FDA issued a Cleared decision on October 22, 1998 after a review of 127 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 The Olympus Optical Co. devices

FDA 510(k) Submission Details - K982133

510(k) Number K982133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date October 22, 1998
Days to Decision 127 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 122d · This submission: 127d
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 K982133.
KSEA C-MOUNT ARTHROSCOPES
K983142 · Karl Storz Endoscopy · Dec 1998
DCI ENDOSCOPE
K983384 · KARL STORZ Endoscopy-America, Inc. · Nov 1998
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
K983025 · Xomed, Inc. · Nov 1998
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM
K982484 · Electro-Biology, Inc. · Oct 1998
STRYKER HIP ARTHOROSCOPY SET
K982375 · Stryker Endoscopy · Oct 1998
INTEGRATED DRIVE/PUMP SYSTEM
K981636 · Linvatec Corp. · Aug 1998