Cleared Traditional

SPECTRA MEDICAL SAFETY SCAPEL (K091462) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K091462 · Spectra, Inc. · General & Plastic Surgery device
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Dec 2009
Decision
211d
Days
Class 1
Risk

K091462 is an FDA 510(k) clearance for the SPECTRA MEDICAL SAFETY SCAPEL. Classified as Handle, Scalpel (product code GDZ), Class I - General Controls.

Submitted by Spectra, Inc. (Wilmington, US). The FDA issued a Cleared decision on December 15, 2009 after a review of 211 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Spectra, Inc. devices

Submission Details

510(k) Number K091462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2009
Decision Date December 15, 2009
Days to Decision 211 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 115d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDZ Handle, Scalpel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.