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510(k) K771919

FIBER OPTICS SIGMOIDOSCOPE by Propper Mfg. Co., Inc. — Product Code GCP

K771919 is an FDA 510(k) premarket notification submitted by Propper Mfg. Co., Inc. for the device "FIBER OPTICS SIGMOIDOSCOPE". The FDA issued a decision of Substantially Equivalent on October 20, 1977. The device falls under product code GCP (Endoscope, Ac-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500. Propper Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1977
Date Received
October 12, 1977
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 Propper Mfg. Co., Inc.

  • K111453 — STEAM DOT BLU PROCESS INDICATOR (April 5, 2012)
  • K102894 — CLASSIX CHEMICAL STERILIZATION INDICATOR (May 25, 2011)
  • K082620 — ONCE-A-DAY VERTOS TEST PACK (July 8, 2009)
  • K031152 — PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) (August 17, 2004)
  • K991618 — BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR (January 24, 2001)
  • K991276 — PASS/FAIL CHALLENGE PACK (July 12, 1999)
  • K973585 — PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR (November 6, 1998)
  • K972747 — BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) (January 9, 1998)
  • K961156 — ONCE-A-DAY BOWIE AND DICK TEST PACK. (April 1, 1997)
  • K921798 — PROPPER SUPER SERACULT(R) (October 5, 1992)

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)
  • 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)

FDA data resources