Cleared Traditional

MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM (K940011) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K940011 · Phx Technologies Corp. · General & Plastic Surgery device
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May 1994
Decision
134d
Days
Class 2
Risk

K940011 is an FDA 510(k) clearance for the MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM. 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 May 18, 1994 after a review of 134 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Phx Technologies Corp. devices

Submission Details

510(k) Number K940011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1994
Decision Date May 18, 1994
Days to Decision 134 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 115d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K940011.
LAPAROSCOPY DILATION SYSTEM
K942201 · Richard Wolf Medical Instruments Corp. · May 1994
SUCTION AND IRRIGATION TUBES
K942202 · Richard Wolf Medical Instruments Corp. · May 1994
SUTURE MANIPULATOR
K941286 · Richard Wolf Medical Instruments Corp. · May 1994
GORE LAPAROSCOPIC SUTURE PASSER
K935986 · W.L. Gore & Associates, Inc. · May 1994
SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
K940346 · KARL STORZ Endoscopy-America, Inc. · May 1994
INSULATED FORCEPS, BIOPSY FORCEPS, SCISSORS
K935071 · KARL STORZ Endoscopy-America, Inc. · Apr 1994