Cleared Traditional

K940259 - STERILE TROCAR AND 5.7MM SLEEVE

K940259 is an FDA 510(k) clearance for STERILE TROCAR AND 5.7MM SLEEVE, manufactured by Phx Technologies Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K940259 · Phx Technologies Corp. · General & Plastic Surgery device
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Feb 1994
Decision
27d
Days
Class 2
Risk

K940259 is an FDA 510(k) clearance for the STERILE TROCAR AND 5.7MM SLEEVE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Phx Technologies Corp. (Lewisville, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Phx Technologies Corp. devices

FDA 510(k) Submission Details - K940259

510(k) Number K940259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date February 17, 1994
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 723
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K940259.
5,6,7,9,10,11&12MM BLUNT-TIPPED TROCAR OBTURATORS
K934511 · Phx Technologies Corp. · Feb 1994
YANKAUER WITH CONNECTING TUBING
K934750 · Trinity Laboratories, Inc. · Feb 1994
AUTO SUTURE DISPOSABLE OPTICAL TROCAR
K935086 · United States Surgical, A Division of Tyco Healthc · Feb 1994
INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION
K934338 · Innovasive Devices, Inc. · Feb 1994
I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA
K934097 · Sharplan Lasers, Inc. · Feb 1994
LAPAROSCOPIC TROCAR STARTER SCALPEL
K936154 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994