Cleared Traditional

K925226 - SIGHT-PLUS ARTHROSCOPE

K925226 is an FDA 510(k) clearance for SIGHT-PLUS ARTHROSCOPE, manufactured by American Medical Concepts, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K925226 · American Medical Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
285d
Days
Class 2
Risk

K925226 is an FDA 510(k) clearance for the SIGHT-PLUS ARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by American Medical Concepts, Inc. (The Woodlands, US). The FDA issued a Cleared decision on July 28, 1993 after a review of 285 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 American Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K925226

510(k) Number K925226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date July 28, 1993
Days to Decision 285 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
163d slower than avg
Panel avg: 122d · This submission: 285d
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 592
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K925226.
CLARUS SERIES 2100 ENDOSCOPE
K923514 · Clarus Medical Systems, Inc. · Jan 1994
SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.
K924016 · Symbiosis Corp. · Dec 1993
DANEK TISSUE CUTTING AND REMOVAL SYSTEM
K922486 · Sofamor Danek Mfg., Inc. · Oct 1993
RESTORE TUNNEL PLUG
K923069 · Depuy, Inc. · Jun 1993
BURTON H- BASE TABLE - MODEL 1990
K924773 · R.H. Burton Co. · Jun 1993
CITSCOPE, BENDABLE -- MODIFICATION
K924494 · Citation Medical Corp. · May 1993