Cleared Traditional

K871043 - (I) LV AND (II) HV SERIES CANNULA

K871043 is an FDA 510(k) clearance for (I) LV AND (II) HV SERIES CANNULA, manufactured by Celebration Medical 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 37-day FDA review.

K871043 · Celebration Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
37d
Days
Class 1
Risk

K871043 is an FDA 510(k) clearance for the (I) LV AND (II) HV SERIES CANNULA. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Celebration Medical Products, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 23, 1987 after a review of 37 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 Celebration Medical Products, Inc. devices

FDA 510(k) Submission Details - K871043

510(k) Number K871043 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 17, 1987
Decision Date April 23, 1987
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 K871043.
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