510(k) K111002

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 18, 2011
Date Received: April 11, 2011
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).

Other clearances by Sterilmed, Inc.

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K190478 — Reprocessed ViewFlex Xtra ICE Catheter (November 14, 2019)
K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (August 15, 2019)
K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (April 15, 2019)
K161700 — SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D D (November 21, 2016)
K161086 — Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed (September 20, 2016)
K153006 — Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) (June 23, 2016)
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)
K121240 — REPROCESSED ENDOSCOPIC TROCARS (June 11, 2012)
K100080 — REPROCESSED TROCARS, MODEL B5LT AND CB5LT (March 19, 2010)