Cleared Traditional

K812691 - SILICONE IMPLANTS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K812691 · Sutter Biomedical, Inc. · General & Plastic Surgery device
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Nov 1981
Decision
55d
Days
Class 1
Risk

K812691 is an FDA 510(k) clearance for the SILICONE IMPLANTS. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Sutter Biomedical, Inc. (Walker, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 55 days - a notably fast clearance 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: 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 Sutter Biomedical, Inc. devices

Submission Details

510(k) Number K812691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1981
Decision Date November 16, 1981
Days to Decision 55 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
59d faster than avg
Panel avg: 114d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDM Instrument, Manual, Surgical, General Use
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.