Cleared Traditional

IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES (K933353) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 354
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K933353.
MURDOCH LAPAROSCOPE LENS CLEANER
K941092 · Cook, Inc. · Apr 1994
AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II
K940398 · United States Surgical, A Division of Tyco Healthc · Apr 1994
KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC
K934937 · KARL STORZ Endoscopy-America, Inc. · Mar 1994
AUTO SUTURE DISPOSABLE OPTICAL TROCAR
K935086 · United States Surgical, A Division of Tyco Healthc · Feb 1994
LAPAROSCOPIC TROCAR STARTER SCALPEL
K936154 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
NON-INSULATED SCISSORS
K935073 · KARL STORZ Endoscopy-America, Inc. · Jan 1994