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510(k) K872906

SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE by American Silk Sutures, Inc. — Product Code GEA

K872906 is an FDA 510(k) premarket notification submitted by American Silk Sutures, Inc. for the device "SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE". The FDA issued a decision of Substantially Equivalent on August 11, 1987. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. American Silk Sutures, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1987
Date Received
July 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by American Silk Sutures, Inc.

  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K904514 — STRUNG TELFA NON-ADHERENT SPONGE (March 27, 1991)
  • K902921 — RAYON NEUROLOGICAL SPONGE (September 18, 1990)
  • K872810 — STRUNG DENTAL ROLLS (December 4, 1987)
  • K872951 — AMERICAN BRAIN RETRACTOR COVER (September 16, 1987)
  • K872905 — AMERICAN NASAL SPONGE (September 4, 1987)
  • K872809 — GAUZE CHERRY SPONGE (August 4, 1987)
  • K872806 — STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG (August 4, 1987)
  • K872808 — CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 (August 4, 1987)
  • K872807 — NON-WOVEN TRACHEOTOMY SPONGE (August 4, 1987)

Other clearances for product code GEA

  • K003965 — MRI SAFE INSTRUMENTS (March 16, 2001)
  • K982472 — GENICON TROCAR (February 4, 1999)
  • K954599 — CONMED TROGARD ELECTRONIC TROCAR SYSTEM (November 27, 1995)
  • K922460 — ORIGIN SECONDARY CANNULA AND TROCAR (September 16, 1992)
  • K920110 — ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE (April 2, 1992)
  • K911262 — DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER (June 20, 1991)
  • K904881 — DISPOSABLE YANKAUER SUCTION TUBE (March 6, 1991)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)
  • K904218 — SUCTION SYSTEM (October 31, 1990)
  • K901717 — KLEIN MICRO-CANNULA(TM) (May 24, 1990)

FDA data resources