Cleared Traditional

K933353 - IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES

K933353 is an FDA 510(k) clearance for IRRIGATION AND ASPIRATION DEVICE FOR LA..., manufactured by Utah Pioneer Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K933353 · Utah Pioneer Medical, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
228d
Days
Class 2
Risk

K933353 is an FDA 510(k) clearance for the IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Utah Pioneer Medical, Inc. (West Valley City, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 228 days - an extended review 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: 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 Utah Pioneer Medical, Inc. devices

FDA 510(k) Submission Details - K933353

510(k) Number K933353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1993
Decision Date February 22, 1994
Days to Decision 228 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
113d slower than avg
Panel avg: 115d · This submission: 228d
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 1152
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K933353.
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STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
K934094 · Stryker Corp. · Feb 1994
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K932540 · Advanced Surgical, Inc. · Feb 1994
5,6,7,9,10,11&12MM BLUNT-TIPPED TROCAR OBTURATORS
K934511 · Phx Technologies Corp. · Feb 1994