Device Recall Starion Instruments Thermal Ligating Shears

  • 모델명 / 제조번호(시리얼번호)
    STLS 23C: Model numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022  STLS 35C: Model 102-138D, Lot Numbers: 907004 and 907008
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany.
  • 제품 설명
    The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting of natural or synthetic, non-metallic, sutures during surgery.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Starion Instruments, 775 Palomar Ave, Sunnyvale CA 94085-2915
  • 제조사 모회사 (2017)
  • Source
    USFDA