510(k) K121240

REPROCESSED ENDOSCOPIC TROCARS by Sterilmed, Inc. — Product Code NLM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 11, 2012
Date Received: April 24, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Laparoscope, General & Plastic Surgery, Reprocessed
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

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).

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K152090 — Reprocessed Steerable Introducer (March 23, 2016)
K152134 — Reprocessed Vessel Sealer (January 15, 2016)
K150357 — Reprocessed Electrophysiology Diagnostic Catheters (August 27, 2015)

Other clearances for product code NLM

K201511 — Reprocessed Endoscopic Trocars and Sleeves (July 31, 2020)
K182828 — Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer (April 15, 2019)
K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Slee (October 6, 2017)
K172093 — Reprocessed Covidien Trocar (October 5, 2017)
K160740 — Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology (May 6, 2016)
K153258 — Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars (April 5, 2016)
K133414 — REPROCESSED CLOSURE SYSTEM (January 22, 2014)
K132629 — REPROCESSED DILATING TIP TROCARS (December 31, 2013)
K111002 — REPROCESSED ENDOSCOPIC TROCARS (July 18, 2011)
K100080 — REPROCESSED TROCARS, MODEL B5LT AND CB5LT (March 19, 2010)