Cleared Traditional

K872906 - SUCTION TUBE TIP FITS OVER BUSSIE FRAZI...

K872906 is the FDA 510(k) clearance for SUCTION TUBE TIP FITS OVER BUSSIE FRAZI... by American Silk Sutures, Inc.. It is a Class 1 General & Plastic Surgery device (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)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 9
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K872906.
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
K911262 · Ethicon, Inc. · Jun 1991
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
CANNULA
K843187 · Ethicon, Inc. · Oct 1984
FRAZIER SUCTION INSTRUMENT-DISPOS
K832636 · Pilling Co. · Oct 1983