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510(k) K860103

MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE by Endotherapeutics — Product Code GCP

K860103 is an FDA 510(k) premarket notification submitted by Endotherapeutics for the device "MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE". The FDA issued a decision of Substantially Equivalent on February 12, 1986. The device falls under product code GCP (Endoscope, Ac-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500. Endotherapeutics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1986
Date Received
January 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Ac-Powered And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Endotherapeutics

  • K870855 — UROSCAN (June 9, 1987)
  • K860192 — ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE (March 17, 1986)
  • K860102 — MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE (February 12, 1986)
  • K852031 — ENDOPORT 5MM (August 13, 1985)
  • K844619 — ENDONEEDLE (January 9, 1985)
  • K841716 — ENDOPORT EROCAR (June 28, 1984)

Other clearances for product code GCP

  • K954614 — EOS BRAND DISPOSABLE PROCTOSCOPE (April 10, 1996)
  • K896505 — PORGES UNIVERSAL HANDLES (January 30, 1990)
  • K896008 — MODEL 6500 MERCURY ARC LIGHT SOURCE (December 27, 1989)
  • K862424 — STEERABLE CATHETER SYSTEM (September 22, 1986)
  • K843683 — MODULAR FIBERSCOPE SYSTEM (January 18, 1985)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K821999 — ENDOSCOPIC SCLEROTHERAPY BALLOON (August 27, 1982)
  • K801247 — CCD ENDOSCOPE AND ATTACHMENTS (July 28, 1980)
  • K790071 — ENDOSCOPE AND ACCESSORIES (April 2, 1979)
  • K771918 — FIBEO OPTICS ILLUM. SYSTEM (October 20, 1977)

FDA data resources