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510(k) K012644

REPROCESSED TROCARS AND CANNULAS by Surgical Instruments Service and Savings, Inc. — Product Code NLM

K012644 is an FDA 510(k) premarket notification submitted by Surgical Instruments Service and Savings, Inc. for the device "REPROCESSED TROCARS AND CANNULAS". The FDA issued a decision of Substantially Equivalent on July 29, 2002. The device falls under product code NLM (Laparoscope, General & Plastic Surgery, Reprocessed), a Class II device regulated under 21 CFR 876.1500. Surgical Instruments Service and Savings, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2002
Date Received
August 13, 2001
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 Surgical Instruments Service and Savings, Inc.

  • K124033 — MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS (January 7, 2014)
  • K031869 — SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSOR (December 24, 2003)
  • K030179 — MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES (January 24, 2003)
  • K024011 — SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICA (December 19, 2002)
  • K012669 — REPROCESSED ELECTROSURGICAL ELECTRODES (June 27, 2002)
  • K012667 — REPROCESSED ARTHROSCOPIC SHAPERS (June 3, 2002)
  • K012658 — REPROCESSED COMPRESSION LIMB SLEEVES (May 14, 2002)

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)
  • K111002 — REPROCESSED ENDOSCOPIC TROCARS (July 18, 2011)

FDA data resources