Cleared Traditional

K842323 - AMER. EDWARDS LAB FLEXISCOPE OBTURATOR

K842323 is the FDA 510(k) clearance for AMER. EDWARDS LAB FLEXISCOPE OBTURATOR by American Edwards Laboratories. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K842323 · American Edwards Laboratories · Orthopedic device
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Aug 1984
Decision
65d
Days
Class 2
Risk

K842323 is an FDA 510(k) clearance for the AMER. EDWARDS LAB FLEXISCOPE OBTURATOR. 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 17, 1984 after a review of 65 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 American Edwards Laboratories devices

Submission Details

510(k) Number K842323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1984
Decision Date August 17, 1984
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 K842323.
RICHARD ARTHROSCOPE
K843604 · Richards Medical Co., Inc. · Oct 1984
ACUFEX ARTHROSCOPE
K843208 · Acufex Microsurgical, Inc. · Sep 1984
AMERICAN EDWARDS LABS FLEXISCOPE
K841607 · American Edwards Laboratories · Aug 1984
ANTHROSCOPY SYSTEM
K834146 · Cabot Medical Corp. · Mar 1984
CABOT ARTHROSCOPY SYSTEM
K833727 · Cabot Medical Corp. · Dec 1983
ARTHROSCOPY FLUID MGMT. SYSTEM
K832315 · 3M Health Care, Sarns · Oct 1983