Cleared Traditional

K201511 - Reprocessed Endoscopic Trocars and Sleeves

K201511 is the FDA 510(k) clearance for Reprocessed Endoscopic Trocars and Sleeves by Stryker Sustainability Solutions. It is a Class 2 General & Plastic Surgery device (product code NLM) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K201511 · Stryker Sustainability Solutions · General & Plastic Surgery device
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Jul 2020
Decision
56d
Days
Class 2
Risk

K201511 is an FDA 510(k) clearance for the Reprocessed Endoscopic Trocars and Sleeves. Classified as Laparoscope, General & Plastic Surgery, Reprocessed (product code NLM), Class II - Special Controls.

Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on July 31, 2020 after a review of 56 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 Stryker Sustainability Solutions devices

Submission Details

510(k) Number K201511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2020
Decision Date July 31, 2020
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 General & Plastic Surgery devices follow this clearance model.

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

All 8
Devices cleared under the same product code (NLM) and FDA review panel - the closest regulatory comparables to K201511.
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 ENDOSCOPIC TROCARS
K121240 · Sterilmed, Inc. · Jun 2012
REPROCESSED ENDOSCOPIC TROCARS
K111002 · Sterilmed, Inc. · Jul 2011
REPROCESSED ENDOSCOPIC TROCAR
K052299 · Sterilmed, Inc. · May 2006
REPROCESSED ENDOSCOPIC TROCAR
K043592 · Sterilmed, Inc. · May 2005