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510(k) K852031

ENDOPORT 5MM by Endotherapeutics — Product Code HET

K852031 is an FDA 510(k) premarket notification submitted by Endotherapeutics for the device "ENDOPORT 5MM". The FDA issued a decision of Substantially Equivalent on August 13, 1985. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Endotherapeutics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1985
Date Received
May 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Endotherapeutics

  • K870855 — UROSCAN (June 9, 1987)
  • K860192 — ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE (March 17, 1986)
  • K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE (February 12, 1986)
  • K860102 — MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE (February 12, 1986)
  • K844619 — ENDONEEDLE (January 9, 1985)
  • K841716 — ENDOPORT EROCAR (June 28, 1984)

Other clearances for product code HET

  • K250939 — SIRIUS Endoscope System (PR-SI-1230) (August 29, 2025)
  • K243821 — i-Cut (April 25, 2025)
  • K221642 — SIRIUS Endoscope System (December 12, 2022)
  • K210116 — Video Endoscopy System, 3D Video Endoscopy System (October 13, 2021)
  • K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (September 17, 2021)
  • K210104 — SurroundScope System (July 8, 2021)
  • K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera (March 12, 2021)
  • K200216 — 4K UHD Camera System (August 21, 2020)
  • K200638 — LAP-iX Suction Irrigation (April 3, 2020)
  • K190190 — WV1 Endoscope (November 1, 2019)

FDA data resources