Cleared Traditional

K942306 - IRRIGATION/ASPIRATION INSTRUMENT

K942306 is the FDA 510(k) clearance for IRRIGATION/ASPIRATION INSTRUMENT by Megadyne Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K942306 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
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Sep 1994
Decision
133d
Days
Class 2
Risk

K942306 is an FDA 510(k) clearance for the IRRIGATION/ASPIRATION INSTRUMENT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Draper, US). The FDA issued a Cleared decision on September 23, 1994 after a review of 133 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 Megadyne Medical Products, Inc. devices

Submission Details

510(k) Number K942306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1994
Decision Date September 23, 1994
Days to Decision 133 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 115d · This submission: 133d
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 691
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K942306.
BABCOCK/BOWEL CLAMP FORCEPS
K940790 · Richard Wolf Medical Instruments Corp. · Nov 1994
AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS
K944467 · Aesculap, Inc. · Oct 1994
GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER
K942574 · Acufex Microsurgical, Inc. · Sep 1994
ORIGIN BALLOON ANCHOR
K944304 · Origin Medsystems, Inc. · Sep 1994
KARL STORZ FLUID LIGHT CABLES
K944224 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH
K935277 · KARL STORZ Endoscopy-America, Inc. · Sep 1994