Cleared Traditional

K950378 - ARGUS LAPAROSCOPY INSTRUMENT SYSTEM

K950378 is an FDA 510(k) clearance for ARGUS LAPAROSCOPY INSTRUMENT SYSTEM, manufactured by Argus Medical Co., Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K950378 · Argus Medical Co., Inc. · General & Plastic Surgery device
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Feb 1995
Decision
9d
Days
Class 2
Risk

K950378 is an FDA 510(k) clearance for the ARGUS LAPAROSCOPY INSTRUMENT SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Argus Medical Co., Inc. (Walnut, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 9 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 Argus Medical Co., Inc. devices

FDA 510(k) Submission Details - K950378

510(k) Number K950378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date February 09, 1995
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K950378.
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KARL STORZ KNOT TIER
K945890 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
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K950336 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
K950198 · United States Surgical, A Division of Tyco Healthc · Feb 1995
KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR
K946330 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
SYMBIOSIS BIPOLAR SCISSORS
K950286 · Symbiosis Corp. · Feb 1995
CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE
K950170 · Conmedcorp · Feb 1995