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510(k) K111002

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

K111002 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED ENDOSCOPIC TROCARS". The FDA issued a decision of Substantially Equivalent on July 18, 2011. The device falls under product code NLM (Laparoscope, General & Plastic Surgery, Reprocessed), a Class II device regulated under 21 CFR 876.1500. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K254149 — Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens S (June 29, 2026)
  • K240826 — Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapo (October 11, 2024)
  • 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)

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)

FDA data resources