Cleared Traditional

K033578 - REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033578 · Clearmedical, Inc. · General & Plastic Surgery device
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Jul 2005
Decision
606d
Days
Class 2
Risk

K033578 is an FDA 510(k) clearance for the REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS. Classified as Staple, Implantable, Reprocessed (product code NLL), Class II - Special Controls.

Submitted by Clearmedical, Inc. (Bellevue, US). The FDA issued a Cleared decision on July 11, 2005 after a review of 606 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Clearmedical, Inc. devices

Submission Details

510(k) Number K033578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2003
Decision Date July 11, 2005
Days to Decision 606 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
492d slower than avg
Panel avg: 114d · This submission: 606d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NLL Staple, Implantable, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.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 General & Plastic Surgery devices follow this clearance model.