Cleared Traditional

K841607 - AMERICAN EDWARDS LABS FLEXISCOPE

K841607 is the FDA 510(k) clearance for AMERICAN EDWARDS LABS FLEXISCOPE by American Edwards Laboratories. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 364
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