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510(k) K843468

PHARMA-PLAST SUCTION SET TYPE YANKAUER by Zimmar Consulting , Ltd. — Product Code GEA

K843468 is an FDA 510(k) premarket notification submitted by Zimmar Consulting , Ltd. for the device "PHARMA-PLAST SUCTION SET TYPE YANKAUER". The FDA issued a decision of Substantially Equivalent on November 23, 1984. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Zimmar Consulting , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1984
Date Received
September 6, 1984
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 Zimmar Consulting , Ltd.

  • K860322 — CLINISET INFUSION SET (April 7, 1986)
  • K843477 — PHARMA-PLAST RECTAL TIP (December 5, 1984)
  • K843478 — PHARMA-PLAST URIDROP-URIDOME (December 5, 1984)
  • K843469 — PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- (November 19, 1984)
  • K843466 — PHARMA-PLAST OXYGEN CATHETER (November 19, 1984)
  • K843467 — PHARMA-PLAST NASAL OXYGEN CANNULA (November 19, 1984)
  • K843470 — PHARMA-PLAST CONNECTING TUBE TYPE SUCT- (November 16, 1984)
  • K843475 — PHARMA-PLAST SINGLE USE OVERSHOES (October 31, 1984)
  • K843472 — PHARMA-PLAST SYRINGE WITH NEEDLE (October 31, 1984)
  • K843471 — PHARMA-PLAST SYRINGE (October 31, 1984)

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