Cleared Traditional

K841249 - SUCTION CANNULAS

K841249 is an FDA 510(k) clearance for SUCTION CANNULAS, manufactured by Custom Surgical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K841249 · Custom Surgical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
75d
Days
Class 1
Risk

K841249 is an FDA 510(k) clearance for the SUCTION CANNULAS. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Custom Surgical Products, Inc. (Bossier City, US). The FDA issued a Cleared decision on June 4, 1984 after a review of 75 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 Custom Surgical Products, Inc. devices

FDA 510(k) Submission Details - K841249

510(k) Number K841249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1984
Decision Date June 04, 1984
Days to Decision 75 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
40d faster than avg
Panel avg: 115d · This submission: 75d
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 K841249.
SUCTION SYSTEM
K861306 · Axiom Medical, Inc. · Jun 1986
PHARMA-PLAST SUCTION SET TYPE YANKAUER
K843468 · Zimmar Consulting , Ltd. · Nov 1984
CANNULA
K843187 · Ethicon, Inc. · Oct 1984
PADGETT SUCTION CANNULA
K833717 · Advanced Biosearch Assn. · Dec 1983
FRAZIER SUCTION INSTRUMENT-DISPOS
K832636 · Pilling Co. · Oct 1983
MODEL 1301 BIOTAC (TM)
K810627 · Progress Mankind Technology · Apr 1981