Cleared Traditional

K133414 - REPROCESSED CLOSURE SYSTEM

K133414 is an FDA 510(k) clearance for REPROCESSED CLOSURE SYSTEM, manufactured by Sterilmed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NLM cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K133414 · Sterilmed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
76d
Days
Class 2
Risk

K133414 is an FDA 510(k) clearance for the REPROCESSED CLOSURE SYSTEM. Classified as Laparoscope, General & Plastic Surgery, Reprocessed (product code NLM), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sterilmed, Inc. devices

FDA 510(k) Submission Details - K133414

510(k) Number K133414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2013
Decision Date January 22, 2014
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLM Device Classification - Class 2, Special Controls

Product Code NLM Laparoscope, General & Plastic Surgery, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. This Device Is Indicated For Reuse/reprocessing. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.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 - NLM Laparoscope, General & Plastic Surgery, Reprocessed

All 21
Devices cleared under the same product code (NLM) and FDA review panel - the closest regulatory comparables to K133414.
Reprocessed Covidien Trocar
K172093 · Renovo, Inc. · Oct 2017
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
K160740 · Surgical Instrument Service and Savings, Inc. · May 2016
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
K153258 · Surgical Instrument Service and Savings (Dba Medline Renewal · Apr 2016
REPROCESSED DILATING TIP TROCARS
K132629 · Stryker Sustainability Solutions · Dec 2013
REPROCESSED ENDOSCOPIC TROCARS
K121240 · Sterilmed, Inc. · Jun 2012
REPROCESSED ENDOSCOPIC TROCARS
K111002 · Sterilmed, Inc. · Jul 2011