Cleared Traditional

K932653 - SWISSTEK 2000(TM) CAST REMOVAL SYSTEM

K932653 is an FDA 510(k) clearance for SWISSTEK 2000(TM) CAST REMOVAL SYSTEM, manufactured by Carapace, Inc.. The device is a Class 1 Orthopedic device with product code LGH cleared through the Traditional 510(k) pathway after a 240-day FDA review.

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

FDA 510(k) Submission Details - K932653

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 122d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

LGH Device Classification - Class 1, General Controls

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.