Cleared Traditional

K862936 - NEWMAN CANNULAE SYSTEM (NCS)

K862936 is an FDA 510(k) clearance for NEWMAN CANNULAE SYSTEM (NCS), manufactured by Byron Medical. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K862936 · Byron Medical · General & Plastic Surgery device
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Aug 1986
Decision
10d
Days
Class 1
Risk

K862936 is an FDA 510(k) clearance for the NEWMAN CANNULAE SYSTEM (NCS). Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Byron Medical (Tucson, US). The FDA issued a Cleared decision on August 14, 1986 after a review of 10 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 Byron Medical devices

FDA 510(k) Submission Details - K862936

510(k) Number K862936 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 04, 1986
Decision Date August 14, 1986
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
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 11
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K862936.
SUCTION SYSTEM
K904218 · Axiom Medical, Inc. · Oct 1990
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
SUCTION SYSTEM
K861306 · Axiom Medical, Inc. · Jun 1986
CANNULA
K843187 · Ethicon, Inc. · Oct 1984
FRAZIER SUCTION INSTRUMENT-DISPOS
K832636 · Pilling Co. · Oct 1983