Cleared Traditional

MSV-2000 VIDEO IMAGING SYSTEM (K942924) - FDA 510(k) Clearance

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

K942924 · Del Medical Systems Corp. · General & Plastic Surgery device
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Oct 1994
Decision
103d
Days
Class 2
Risk

K942924 is an FDA 510(k) clearance for the MSV-2000 VIDEO IMAGING SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Del Medical Systems Corp. (Valhalla, US). The FDA issued a Cleared decision on October 3, 1994 after a review of 103 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 Del Medical Systems Corp. devices

Submission Details

510(k) Number K942924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1994
Decision Date October 03, 1994
Days to Decision 103 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 115d · This submission: 103d
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 353
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K942924.
TROCAR ( ACCESORY)
K945457 · United States Surgical, A Division of Tyco Healthc · Nov 1994
KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS
K945059 · KARL STORZ Endoscopy-America, Inc. · Nov 1994
KARL STORZ RETRACTORS, PROBES, DISSECTORS, HOOKD
K945101 · KARL STORZ Endoscopy-America, Inc. · Nov 1994
AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS
K944467 · Aesculap, Inc. · Oct 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