Cleared Traditional

K911601 - REDDICK TROCAR AND CANNULA

K911601 is an FDA 510(k) clearance for REDDICK TROCAR AND CANNULA, manufactured by Ideal Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K911601 · Ideal Medical, Inc. · General & Plastic Surgery device
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May 1991
Decision
41d
Days
Class 1
Risk

K911601 is an FDA 510(k) clearance for the REDDICK TROCAR AND CANNULA. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Ideal Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on May 21, 1991 after a review of 41 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 Ideal Medical, Inc. devices

FDA 510(k) Submission Details - K911601

510(k) Number K911601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1991
Decision Date May 21, 1991
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

Product Code FSM Tray, Surgical, Instrument
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 - FSM Tray, Surgical, Instrument

All 39
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K911601.
OPEN HEART TRAY
K912053 · Medical Device Inspection Co., Inc. · Aug 1991
HEART CATH TRAY
K912052 · Medical Device Inspection Co., Inc. · Aug 1991
MAJOR BASIN TRAY
K912104 · Medical Device Inspection Co., Inc. · Aug 1991
HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)
K900376 · Pmt Corp. · Apr 1990
STERILE LACERATION TRAY CAT. #749
K900479 · Busse Hospital Disposables, Inc. · Feb 1990
STERILIZATION TRAY, TMJ INSTRUMENT SET
K871924 · Arthropedics, Inc. · Jun 1987