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510(k) K812200

INSUFFLATOR by Reznik Instruments — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1981
Date Received
August 4, 1981
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 Reznik Instruments

  • K812205 — FORCEP (October 26, 1981)
  • K812201 — PHOTOGRAPHIC EQUIPMENT (October 19, 1981)
  • K812203 — ELECTROSURGICAL UNIT (October 13, 1981)
  • K812199 — TROCAR & TROCAR SLEEVES (October 13, 1981)
  • K812204 — UTERINE MANIPULATORS (October 13, 1981)
  • K812206 — LAPAROSCOPE (October 13, 1981)
  • K812202 — FIBER OPTIC LIGHT SOURCE (September 29, 1981)
  • K812198 — ACCESSORIES(PROBES, SUCTION TUBES, ETC.) (September 11, 1981)

Other clearances for product code HIF

  • K250388 — ENDOFLATOR + (September 22, 2025)
  • K242772 — AirSurgN Insufflator (10030/AirSurgN) (April 11, 2025)
  • K243527 — High Flow Insufflation Unit (UHI-4) (January 13, 2025)
  • K242536 — TauTona Pneumoperitoneum Assist Device (TPAD) (October 15, 2024)
  • K232464 — VereSee Optical Veres Needle System (May 2, 2024)
  • K232902 — EVA15 insufflator (May 2, 2024)
  • K233020 — TauTona Pneumoperitoneum Assist Device (TPAD) (January 12, 2024)
  • K232401 — Disposable Veress Needles (December 14, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)
  • K230239 — AirSeal iFS System; AirSeal dV Solution (September 20, 2023)