Home / 510(k) Clearances / K120898

510(k) K120898

KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA by Richard Wolf Medical Instruments Corp. — Product Code OTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2012
Date Received
March 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscopic Single Port Access Device
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

Other clearances by Richard Wolf Medical Instruments Corp.

  • K151282 — core nova Complete Operating Room Endoscopy (January 12, 2016)
  • K130423 — THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 (April 3, 2013)
  • K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (September 20, 2012)
  • K090776 — MEGAPULSE LASER SYSTEM AND FIBERS (June 2, 2009)
  • K080617 — POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES (June 27, 2008)
  • K080977 — 3 CCD ENDOCAM 5550 (May 14, 2008)
  • K071292 — VIEW MD OFFICE SYSTEM, MODEL 41066.5540 (July 19, 2007)
  • K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (March 22, 2007)
  • K051276 — HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM (October 28, 2005)
  • K051176 — FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 (October 5, 2005)

Other clearances for product code OTJ

  • K232062 — Uni-port (January 16, 2024)
  • K220081 — CORE-SPORT (September 28, 2022)
  • K202688 — AFS Medical Sterile Single-Use Access Port System (October 14, 2021)
  • K160797 — FMX314 Surgical Platform (August 26, 2016)
  • K152598 — Endo Keeper (March 17, 2016)
  • K121309 — ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE (September 6, 2012)
  • K111407 — TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (January 18, 2012)
  • K112196 — OCTOTMPORT (September 14, 2011)
  • K110004 — ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE (January 26, 2011)
  • K101794 — ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT (November 29, 2010)