Cleared Traditional

K120898 - KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA

K120898 is an FDA 510(k) clearance for KEYPORT SYSTEM, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 General & Plastic Surgery device with product code OTJ cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K120898 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
130d
Days
Class 2
Risk

K120898 is an FDA 510(k) clearance for the KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRU.... Classified as Laparoscopic Single Port Access Device (product code OTJ), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on August 3, 2012 after a review of 130 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K120898

510(k) Number K120898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2012
Decision Date August 03, 2012
Days to Decision 130 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
15d slower than avg
Panel avg: 115d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTJ Device Classification - Class 2, Special Controls

Product Code OTJ Laparoscopic Single Port Access Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery.
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 - OTJ Laparoscopic Single Port Access Device

All 9
Devices cleared under the same product code (OTJ) and FDA review panel - the closest regulatory comparables to K120898.
FMX314 Surgical Platform
K160797 · Fortimedix Surgical B.V. · Aug 2016
Endo Keeper
K152598 · Nelis · Mar 2016
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
K121309 · Advanced Surgical Concepts · Sep 2012
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
K111407 · Advanced Surgical Concepts · Jan 2012
OCTOTMPORT
K112196 · Dalim Surgnet Corporation · Sep 2011
ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
K110004 · Advanced Surgical Concepts · Jan 2011