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510(k) K781913

INSUFFALATOR LAPARAOSCOPIC by Kli — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
November 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

Other clearances by Kli

  • K800822 — CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE (June 17, 1980)
  • K800913 — GYNECOLOGICAL CYSTO/URETHROSCOPE (May 14, 1980)
  • K781109 — FORCEPS, ELECTROSURGICAL (September 14, 1978)
  • K781089 — ONE INCISION BI-POLAR ELECTRO. FORCEPS (July 17, 1978)
  • K780955 — SCISSORS, HOOK, ELECTROSURGICAL (June 22, 1978)
  • K780954 — SCISSORS, HOOK, ELECTROSURGICAL (June 22, 1978)
  • K772297 — INSUFFLATOR, MODEL G100 & 200 (January 5, 1978)
  • K772242 — LAPAROSCOPY CONSOLE MODEL VIII (December 20, 1977)
  • K772220 — PROBE, COAGULATION ACCESSORY (December 13, 1977)
  • K772185 — LAPAROSCOPE W/REMOVABLE OPTICS (November 30, 1977)

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  • K233020 — TauTona Pneumoperitoneum Assist Device (TPAD) (January 12, 2024)
  • K232401 — Disposable Veress Needles (December 14, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)
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