Cleared Traditional

K113203 - SONY LMD-2451MT LCD MONITOR

K113203 is an FDA 510(k) clearance for SONY LMD-2451MT LCD MONITOR, manufactured by Sony Electronics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K113203 · Sony Electronics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
116d
Days
Class 2
Risk

K113203 is an FDA 510(k) clearance for the SONY LMD-2451MT LCD MONITOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Sony Electronics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 116 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 Sony Electronics, Inc. devices

FDA 510(k) Submission Details - K113203

510(k) Number K113203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date February 24, 2012
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
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 1066
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K113203.
WOUND PROTECTOR
K120061 · Covidien, Formerly US Surgical A Divison of Tyco H · Mar 2012
ENDOSCOPIC APPLICATOR
K120608 · Micromedics, Inc. · Mar 2012
SURGICAL RETRACTORS
K112659 · Surgical Innovations Plc · Mar 2012
UNIMAX TROCAR SYSTEM
K112358 · Unimax Medical Systems, Inc. · Oct 2011
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
K112456 · Teleflexmedical, Inc. · Oct 2011
THE ESPINER SAC OR E SAC
K111845 · Espiner Medical Limited · Sep 2011