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510(k) K910171

MAXI-FLOW SUCTION SET W/Y CONNECTOR by Adler Instrument Co. — Product Code GAZ

K910171 is an FDA 510(k) premarket notification submitted by Adler Instrument Co. for the device "MAXI-FLOW SUCTION SET W/Y CONNECTOR". The FDA issued a decision of Substantially Equivalent on February 1, 1991. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Adler Instrument Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1991
Date Received
January 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Noninvasive
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Adler Instrument Co.

  • K910170 — MAXI-FLOW SUCTION SET 12 FT. (February 1, 1991)
  • K903209 — MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER (December 21, 1990)
  • K903208 — MAXI-FLOW INSUFFLATOR TUBING SET (December 17, 1990)
  • K900913 — ADLER DISPOSABLE BIPOLAR CORD (April 4, 1990)
  • K841723 — ADLER CUSTOM PROCEDURE PACKS (August 1, 1984)
  • K833264 — ADLER STEAM INDICATOR-GAS INDICATOR (November 3, 1983)
  • K831068 — CONTAINER SYSTEM (May 9, 1983)

Other clearances for product code GAZ

  • K952605 — SUCTION/IRRIGATOR TUBING KIT (September 15, 1995)
  • K945978 — TUBING, NONINVASIVE (January 11, 1995)
  • K930512 — SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES (July 23, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K910471 — MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (March 8, 1991)
  • K910170 — MAXI-FLOW SUCTION SET 12 FT. (February 1, 1991)
  • K882315 — VIR-A-VAC EMPTY (September 26, 1988)
  • K883473 — SURGICAL CONNECTING TUBES (August 25, 1988)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)
  • K861757 — 5 IN 1 CONNECTOR (June 6, 1986)

FDA data resources