Cleared Traditional

K854889 - FLEX-I-GRASP

K854889 is an FDA 510(k) clearance for FLEX-I-GRASP, manufactured by Euro-Med Intl.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K854889 · Euro-Med Intl. · Orthopedic device
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Feb 1986
Decision
77d
Days
Class 2
Risk

K854889 is an FDA 510(k) clearance for the FLEX-I-GRASP. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Euro-Med Intl. (Danville, US). The FDA issued a Cleared decision on February 21, 1986 after a review of 77 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 Euro-Med Intl. devices

FDA 510(k) Submission Details - K854889

510(k) Number K854889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1985
Decision Date February 21, 1986
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
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 539
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K854889.
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
AMERICAN EDWARDS LABORATORIES FLEXISCOPE
K852759 · American Edwards Laboratories · Aug 1985
CO2 FOR ARTHROSCOPY
K852592 · The Anspach Effort, Inc. · Aug 1985
AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE
K851374 · American Edwards Laboratories · Jun 1985