Cleared Traditional

ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) (K896998) - FDA 510(k) Clearance

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

K896998 · S.P.K. Technology, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
171d
Days
Class 2
Risk

K896998 is an FDA 510(k) clearance for the ATRAUCLIP (TANTALUM HEMOSTATIC CLIP). Classified as Clip, Hemostatic (product code MCH), Class II - Special Controls.

Submitted by S.P.K. Technology, Inc. (Seal Beach, US). The FDA issued a Cleared decision on June 1, 1990 after a review of 171 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all S.P.K. Technology, Inc. devices

Submission Details

510(k) Number K896998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1989
Decision Date June 01, 1990
Days to Decision 171 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MCH Clip, Hemostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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.