Cleared Traditional

K872714 - S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS...

K872714 is an FDA 510(k) clearance for S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS..., manufactured by Roseburg SA. The device is a Class 1 General & Plastic Surgery device with product code GBI cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K872714 · Roseburg SA · General & Plastic Surgery device
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Jul 1987
Decision
11d
Days
Class 1
Risk

K872714 is an FDA 510(k) clearance for the S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY. Classified as Material, External Aesthetic Restoration, Used With Adhesive (product code GBI), Class I - General Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 11 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3800 - 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 Roseburg SA devices

FDA 510(k) Submission Details - K872714

510(k) Number K872714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1987
Decision Date July 21, 1987
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

GBI Device Classification - Class 1, General Controls

Product Code GBI Material, External Aesthetic Restoration, Used With Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3800
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.

Regulatory Peers - GBI Material, External Aesthetic Restoration, Used With Adhesive

Devices cleared under the same product code (GBI) and FDA review panel - the closest regulatory comparables to K872714.
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