Cleared Traditional

WIRELESS IMAGE TRANSMITTER UNIT (K120278) - FDA 510(k) Clearance

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

K120278 · Olympus Medical Systems Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
193d
Days
Class 2
Risk

K120278 is an FDA 510(k) clearance for the WIRELESS IMAGE TRANSMITTER UNIT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on August 10, 2012 after a review of 193 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K120278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2012
Decision Date August 10, 2012
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
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 1420
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K120278.
TroKit Laparoscope Lens Wiper
K253994 · TroCare, LLC · Jun 2026
Inno-Port Disposable Bladed Trocar
K252532 · Taiwan Surgical Corporation · Jun 2026
4K NIR/ICG Imaging System
K260318 · Zhejiang Healnoc Technology Co., Ltd. · May 2026
MediBot Needle Driver Uno
K260183 · Parallel Robotics, LLC · May 2026
Laport
K252985 · Sejong Medical Co., Ltd. · May 2026
KARL STORZ Trocars with Valve Seals
K254228 · Karl Storz SE & CO. KG · May 2026