Cleared Traditional

K841607 - AMERICAN EDWARDS LABS FLEXISCOPE

K841607 is an FDA 510(k) clearance for AMERICAN EDWARDS LABS FLEXISCOPE, manufactured by American Edwards Laboratories. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K841607 · American Edwards Laboratories · Orthopedic device
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Aug 1984
Decision
121d
Days
Class 2
Risk

K841607 is an FDA 510(k) clearance for the AMERICAN EDWARDS LABS FLEXISCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by American Edwards Laboratories (Walker, US). The FDA issued a Cleared decision on August 18, 1984 after a review of 121 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 American Edwards Laboratories devices

FDA 510(k) Submission Details - K841607

510(k) Number K841607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1984
Decision Date August 18, 1984
Days to Decision 121 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 122d · This submission: 121d
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 522
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K841607.
CODMAN ARTHROSCOPE
K851229 · Codman & Shurtleff, Inc. · May 1985
RICHARD ARTHROSCOPE
K843604 · Richards Medical Co., Inc. · Oct 1984
ACUFEX ARTHROSCOPE
K843208 · Acufex Microsurgical, Inc. · Sep 1984
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR
K842323 · American Edwards Laboratories · Aug 1984
ANTHROSCOPY SYSTEM
K834146 · Cabot Medical Corp. · Mar 1984
CABOT ARTHROSCOPY SYSTEM
K833727 · Cabot Medical Corp. · Dec 1983