Cleared Traditional

K152598 - Endo Keeper

K152598 is an FDA 510(k) clearance for Endo Keeper, manufactured by Nelis. The device is a Class 2 General & Plastic Surgery device with product code OTJ cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K152598 · Nelis · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
188d
Days
Class 2
Risk

K152598 is an FDA 510(k) clearance for the Endo Keeper. Classified as Laparoscopic Single Port Access Device (product code OTJ), Class II - Special Controls.

Submitted by Nelis (Bucheon, KR). The FDA issued a Cleared decision on March 17, 2016 after a review of 188 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.

FDA 510(k) Submission Details - K152598

510(k) Number K152598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2015
Decision Date March 17, 2016
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
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 Consultant

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PETER CHUNG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OTJ Laparoscopic Single Port Access Device

All 10
Devices cleared under the same product code (OTJ) and FDA review panel - the closest regulatory comparables to K152598.
CORE-SPORT
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ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
K121309 · Advanced Surgical Concepts · Sep 2012
KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
K120898 · Richard Wolf Medical Instruments Corp. · Aug 2012
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
K111407 · Advanced Surgical Concepts · Jan 2012