Cleared Traditional

K872906 - SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE

K872906 is an FDA 510(k) clearance for SUCTION TUBE TIP FITS OVER BUSSIE FRAZI..., manufactured by American Silk Sutures, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K872906 · American Silk Sutures, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Aug 1987
Decision
18d
Days
Class 1
Risk

K872906 is an FDA 510(k) clearance for the SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on August 11, 1987 after a review of 18 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 American Silk Sutures, Inc. devices

FDA 510(k) Submission Details - K872906

510(k) Number K872906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1987
Decision Date August 11, 1987
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

GEA Device Classification - Class 1, General Controls

Product Code GEA Cannula, Surgical, General & Plastic Surgery
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.

Regulatory Peers - GEA Cannula, Surgical, General & Plastic Surgery

All 18
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K872906.
SOFT SUCTION ADAPTER
K895684 · Applied Medical Technologies · Nov 1989
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*
K896434 · United States Surgical, A Division of Tyco Healthc · Nov 1989
COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
K872214 · CooperVision, Inc. · Aug 1987
DISPOSABLE SUCTION CANNULA NO. 902008-000
K863293 · Lifestream Int'L, Inc. · Sep 1986
NEWMAN CANNULAE SYSTEM (NCS)
K862936 · Byron Medical · Aug 1986
SUCTION SYSTEM
K861306 · Axiom Medical, Inc. · Jun 1986