Cleared Traditional

K852759 - AMERICAN EDWARDS LABORATORIES FLEXISCOPE

K852759 is the FDA 510(k) clearance for AMERICAN EDWARDS LABORATORIES FLEXISCOPE by American Edwards Laboratories. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K852759 · American Edwards Laboratories · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
55d
Days
Class 2
Risk

K852759 is an FDA 510(k) clearance for the AMERICAN EDWARDS LABORATORIES FLEXISCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 55 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 K852759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1985
Decision Date August 22, 1985
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 K852759.
CONCEPT ARTHROSCOPIC KNIFE
K862658 · Concept, Inc. · Jul 1986
CABOT VIDEOSCOPE
K861859 · Cabot Medical Corp. · May 1986
ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH
K861268 · Orthopedic Systems, Inc. · May 1986
CO2 FOR ARTHROSCOPY
K852592 · The Anspach Effort, Inc. · Aug 1985
AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE
K851374 · American Edwards Laboratories · Jun 1985
CODMAN ARTHROSCOPE
K851229 · Codman & Shurtleff, Inc. · May 1985