Cleared Traditional

ESA ELECTROSURGICAL ARTHROSCOPY GENERA (K830499) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830499 · Concept, Inc. · Orthopedic device
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Mar 1983
Decision
29d
Days
Class 2
Risk

K830499 is an FDA 510(k) clearance for the ESA ELECTROSURGICAL ARTHROSCOPY GENERA. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Concept, Inc. (Walker, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Concept, Inc. devices

Submission Details

510(k) Number K830499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1983
Decision Date March 17, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
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 178
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K830499.
THE KARL STORZ MODEL 28805 ARTHRO PUMP
K871621 · KARL STORZ Endoscopy-America, Inc. · Jun 1987
SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM
K870915 · C.R. Bard, Inc. · Apr 1987
CODMAN ARTHROSCOPE
K851229 · Codman & Shurtleff, Inc. · May 1985
ZIMMER ARTHROSCOPY SYSTEM
K811596 · Zimmer, Inc. · Jun 1981
SURGICAL INSTRUMENTS FOR USE W/ZIMMER
K811675 · Zimmer, Inc. · Jun 1981
NEEDLE, SPRAY
K770710 · Richard Wolf Medical Instruments Corp. · Apr 1977