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510(k) K951119

NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM by American Hydro-Surgical Instruments, Inc. — Product Code GCX

K951119 is an FDA 510(k) premarket notification submitted by American Hydro-Surgical Instruments, Inc. for the device "NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 1995. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. American Hydro-Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1995
Date Received
March 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by American Hydro-Surgical Instruments, Inc.

  • K953574 — NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER (September 29, 1995)
  • K953481 — NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER (August 16, 1995)
  • K952070 — NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TR (July 26, 1995)
  • K946380 — NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA ( (July 6, 1995)
  • K951300 — NEZHAT-DORSEY THERMAL RETENTION SYSTEM (June 20, 1995)
  • K950499 — NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS (June 16, 1995)
  • K952421 — NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS (June 8, 1995)
  • K951733 — NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTRO (May 31, 1995)
  • K951732 — NEZHAT-DORESEY PENCIL-GRIP HANDLES (May 24, 1995)
  • K951731 — NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS (May 16, 1995)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)

FDA data resources