Cleared Traditional

K983142 - KSEA C-MOUNT ARTHROSCOPES

K983142 is the FDA 510(k) clearance for KSEA C-MOUNT ARTHROSCOPES by Karl Storz Endoscopy. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K983142 · Karl Storz Endoscopy · Orthopedic device
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Dec 1998
Decision
90d
Days
Class 2
Risk

K983142 is an FDA 510(k) clearance for the KSEA C-MOUNT ARTHROSCOPES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on December 7, 1998 after a review of 90 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 Karl Storz Endoscopy devices

Submission Details

510(k) Number K983142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1998
Decision Date December 07, 1998
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 382
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K983142.
KSEA EPIDUROSCOPE
K991051 · KARL STORZ Endoscopy-America, Inc. · Jun 1999
ABLATOR ELECTRODE
K983652 · Linvatec Corp. · Mar 1999
FLEXPOSURE RETRACTOR
K983144 · Endius, Inc. · Feb 1999
DCI ENDOSCOPE
K983384 · KARL STORZ Endoscopy-America, Inc. · Nov 1998
XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
K983025 · Xomed, Inc. · Nov 1998
STRYKER HIP ARTHOROSCOPY SET
K982375 · Stryker Endoscopy · Oct 1998