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510(k) K954614

EOS BRAND DISPOSABLE PROCTOSCOPE by North Eos Industries, Inc. — Product Code GCP

K954614 is an FDA 510(k) premarket notification submitted by North Eos Industries, Inc. for the device "EOS BRAND DISPOSABLE PROCTOSCOPE". The FDA issued a decision of Substantially Equivalent on April 10, 1996. The device falls under product code GCP (Endoscope, Ac-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500. North Eos Industries, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1996
Date Received
October 5, 1995
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 North Eos Industries, Inc.

  • K963685 — EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER (October 11, 1996)
  • K963377 — EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC (October 4, 1996)

Other clearances for product code GCP

  • K896505 — PORGES UNIVERSAL HANDLES (January 30, 1990)
  • K896008 — MODEL 6500 MERCURY ARC LIGHT SOURCE (December 27, 1989)
  • K862424 — STEERABLE CATHETER SYSTEM (September 22, 1986)
  • K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE (February 12, 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)
  • K771920 — FIBER OPTICS PROCTOSCOPE (October 20, 1977)

FDA data resources