Cleared Traditional

K033579 - REPROCESSED MULTIPLE CLIP APPLIERS (FDA 510(k) Clearance)

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

K033579 · Clearmedical, Inc. · General & Plastic Surgery device
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Jul 2005
Decision
606d
Days
Class 2
Risk

K033579 is an FDA 510(k) clearance for the REPROCESSED MULTIPLE CLIP APPLIERS. Classified as Clip, Implantable, Reprocessed (product code NMJ), 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 878.4300 - 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 K033579 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 NMJ Clip, Implantable, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
Definition The "implantable Clip, Reprocessed" Is Intended To Connect Internal Tissues To Aid In Healing. It Is Not Absorbable. This Device Is Indicated For Reuse/reprocessing. 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.