Cleared Traditional

K982133 - OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT

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
Combination Product No
PCCP Authorized No
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 548
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K982133.
DCI ENDOSCOPE
K983384 · KARL STORZ Endoscopy-America, Inc. · Nov 1998
ARTHRO-SURGIMAT-1500
K983910 · W.O.M. World of Medicine GmbH · 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
HYDROCISION ARTHROJET SYSTEM
K982266 · Hydrocision, Inc. · Sep 1998