Cleared Traditional

K932653 - SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (FDA 510(k) Clearance)

Class I Orthopedic device.

K932653 · Carapace, Inc. · Orthopedic device
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Jan 1994
Decision
240d
Days
Class 1
Risk

K932653 is an FDA 510(k) clearance for the SWISSTEK 2000(TM) CAST REMOVAL SYSTEM. Classified as Instrument, Cast Removal, Ac-powered (product code LGH), Class I - General Controls.

Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on January 28, 1994 after a review of 240 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5960 - 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 Carapace, Inc. devices

Submission Details

510(k) Number K932653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date January 28, 1994
Days to Decision 240 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 122d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGH Instrument, Cast Removal, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5960
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.