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510(k) K841409

BUSH NECK W/PLUG by Warne Surgical Products, Ltd. — Product Code BYZ

K841409 is an FDA 510(k) premarket notification submitted by Warne Surgical Products, Ltd. for the device "BUSH NECK W/PLUG". The FDA issued a decision of Substantially Equivalent on April 18, 1984. The device falls under product code BYZ (Trap, Sterile Specimen), a Class II device regulated under 21 CFR 880.6740. Warne Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1984
Date Received
April 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trap, Sterile Specimen
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Warne Surgical Products, Ltd.

  • K850696 — WSP CODE 4300 DIOMASTER DIAGNOSTIC (May 17, 1985)
  • K850694 — WSP CODE 4310 STRESSCATH (May 17, 1985)
  • K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC (May 16, 1985)
  • K850693 — WSP CODE 4315 PADTEST (May 10, 1985)
  • K841511 — HAEMATURIA CATHETERS (July 12, 1984)
  • K840687 — KIDNEY TRANSPLANT CATHETER (June 7, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)
  • K841410 — BUSH NECK W/TAP (April 18, 1984)
  • K840702 — SECURE W/25MM DIAM. SHEATH & ADHESIVE (March 22, 1984)

Other clearances for product code BYZ

  • K925412 — ELECTROMEDICS TISSUE TRAP/ #TT280 (February 5, 1993)
  • K913643 — MUCOUS SPECIMEN TRAP (October 10, 1991)
  • K902883 — TISSUE/POLYP TRAP SYSTEM (September 12, 1990)
  • K840253 — ONE-WAY AIR VALVE (April 5, 1984)
  • K834467 — SPECIMEN TRAP (February 17, 1984)
  • K822556 — CRITICAL MEASUREMENT UNIT (October 18, 1982)
  • K822557 — SPECIMEN ADAPTOR (October 18, 1982)
  • K791847 — ASPRI-LUKE (October 2, 1979)

FDA data resources