Cleared Traditional

K883694 - TENSIOMETER

K883694 is the FDA 510(k) clearance for TENSIOMETER by W.L. Gore & Associates, Inc.. It is a Class 1 Orthopedic device (product code LXH) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K883694 · W.L. Gore & Associates, Inc. · Orthopedic device
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Nov 1988
Decision
85d
Days
Class 1
Risk

K883694 is an FDA 510(k) clearance for the TENSIOMETER. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on November 22, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K883694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1988
Decision Date November 22, 1988
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXH Orthopedic Manual Surgical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LXH Orthopedic Manual Surgical Instrument

All 22
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K883694.
DRIVER/EXTRACTOR
K903257 · Onyx Medical Corp. · Jul 1990
T-HANDLE HEX WRENCH
K903270 · Onyx Medical Corp. · Jul 1990
COHN TARGETEER
K891903 · Orthopedic Systems, Inc. · May 1989
PATELLAR TENDON GRAFT GUIDE
K880413 · Concept, Inc. · Mar 1988
ACROMED SPINAL SURGERY INSTRUMENTS
K860131 · Buckman Co., Inc. · Mar 1986
HENNING MENISCAL SUTURE KIT
K843942 · Stryker Corp. · Apr 1985