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510(k) K821999

ENDOSCOPIC SCLEROTHERAPY BALLOON by Retech — Product Code GCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1982
Date Received
July 7, 1982
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

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  • 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)
  • K801247 — CCD ENDOSCOPE AND ATTACHMENTS (July 28, 1980)
  • K790071 — ENDOSCOPE AND ACCESSORIES (April 2, 1979)
  • K771918 — FIBEO OPTICS ILLUM. SYSTEM (October 20, 1977)