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510(k) K904881

DISPOSABLE YANKAUER SUCTION TUBE by Pilling Medical S.A. — Product Code GEA

K904881 is an FDA 510(k) premarket notification submitted by Pilling Medical S.A. for the device "DISPOSABLE YANKAUER SUCTION TUBE". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1991
Date Received
October 24, 1990
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 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)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)
  • K904218 — SUCTION SYSTEM (October 31, 1990)
  • K901717 — KLEIN MICRO-CANNULA(TM) (May 24, 1990)
  • K901718 — KLEIN LAMPREY-CANNULA(TM) (May 24, 1990)

FDA data resources