Cleared Traditional

K121240 - REPROCESSED ENDOSCOPIC TROCARS

K121240 is the FDA 510(k) clearance for REPROCESSED ENDOSCOPIC TROCARS by Sterilmed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code NLM) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K121240 · Sterilmed, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2012
Decision
48d
Days
Class 2
Risk

K121240 is an FDA 510(k) clearance for the REPROCESSED ENDOSCOPIC TROCARS. 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 June 11, 2012 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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

Submission Details

510(k) Number K121240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2012
Decision Date June 11, 2012
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 130d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - NLM Laparoscope, General & Plastic Surgery, Reprocessed

All 11
Devices cleared under the same product code (NLM) and FDA review panel - the closest regulatory comparables to K121240.
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
K182828 · Surgical Instrument Service and Savings, Inc. · Apr 2019
REPROCESSED CLOSURE SYSTEM
K133414 · Sterilmed, Inc. · Jan 2014
REPROCESSED DILATING TIP TROCARS
K132629 · Stryker Sustainability Solutions · Dec 2013
REPROCESSED ENDOSCOPIC TROCARS
K111002 · Sterilmed, Inc. · Jul 2011
REPROCESSED ENDOSCOPIC TROCAR
K052299 · Sterilmed, Inc. · May 2006
REPROCESSED ENDOSCOPIC TROCAR
K043592 · Sterilmed, Inc. · May 2005