Cleared Traditional

K901677 - CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER (FDA 510(k) Clearance)

Class I Orthopedic device.

K901677 · Buckman Co., Inc. · Orthopedic device
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Apr 1990
Decision
13d
Days
Class 1
Risk

K901677 is an FDA 510(k) clearance for the CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER. Classified as Instrument, Cast Removal, Ac-powered (product code LGH), Class I - General Controls.

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 13 days - a notably fast clearance 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: 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K901677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1990
Decision Date April 23, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 122d · This submission: 13d
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.