Cleared Traditional

K930511 - STEALTH SURGICAL IRRIGATOR ASPIRATOR

K930511 is an FDA 510(k) clearance for STEALTH SURGICAL IRRIGATOR ASPIRATOR, manufactured by W. J. Medical Instruments, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K930511 · W. J. Medical Instruments, Inc. · General & Plastic Surgery device
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Jun 1993
Decision
144d
Days
Class 2
Risk

K930511 is an FDA 510(k) clearance for the STEALTH SURGICAL IRRIGATOR ASPIRATOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by W. J. Medical Instruments, Inc. (Newbury Park, US). The FDA issued a Cleared decision on June 25, 1993 after a review of 144 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 W. J. Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K930511

510(k) Number K930511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date June 25, 1993
Days to Decision 144 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
29d slower than avg
Panel avg: 115d · This submission: 144d
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 K930511.
ENDOPATH ENDOSCOPIC TISSUE RETRACTOR
K924916 · Ethicon Endo-Surgery, Inc. · Jun 1993
ORC 10.0MM SUCTION PROBE
K925147 · O.R. Concepts, Inc. · Jun 1993
FUJINON VIDEO LAPAROSCOPE, MODIFICATION
K926444 · Fujinon, Inc. · Jun 1993
KARL STORZ 495N SERIES FIBER OPTIC LIGHT CABLES
K931018 · KARL STORZ Endoscopy-America, Inc. · Jun 1993
SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY
K930147 · Davol, Inc. · Jun 1993
ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS
K930933 · Ethicon, Inc. · Jun 1993