510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201511Substantially Equivalent

Reprocessed Endoscopic Trocars and Sleeves

Stryker Sustainability Solutions, Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201511 is the FDA 510(k) clearance record for Reprocessed Endoscopic Trocars and Sleeves, a class II device, cleared for Stryker Sustainability Solutions on under FDA product code NLM (Laparoscope, General & Plastic Surgery, Reprocessed). FDA's definition for product code NLM reads: "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...". FDA records list 88 510(k) clearances for Stryker Sustainability Solutions, from to . As of , FDA records show no recalls naming K201511.

Clearance record

Decision date
Received
(56 days to decision)
Product code
NLM Laparoscope, General & Plastic Surgery, Reprocessed
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Stryker Sustainability Solutions 1810 W Dr.Ake Dr., Tempe AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLM

Trailing 12 months

FDA records hold no clearances under product code NLM in the trailing twelve months.

FDA records show no clearances under product code NLM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NLM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260