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510(k) K112196

OCTOTMPORT by Dalim Surgnet Corporation — Product Code OTJ

K112196 is an FDA 510(k) premarket notification submitted by Dalim Surgnet Corporation for the device "OCTOTMPORT". The FDA issued a decision of Substantially Equivalent on September 14, 2011. The device falls under product code OTJ (Laparoscopic Single Port Access Device), a Class II device regulated under 21 CFR 876.1500. Dalim Surgnet Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2011
Date Received
August 1, 2011
Clearance Type
Special
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 Dalim Surgnet Corporation

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)
  • K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR (August 3, 2012)
  • K111407 — TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (January 18, 2012)
  • 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)

FDA data resources