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510(k) K022318

VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES by Vomed Volzer Medizintechnik GmbH & Co. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2002
Date Received
July 8, 2002
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 Vomed Volzer Medizintechnik GmbH & Co.

  • K023019 — VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 (December 10, 2002)
  • K022257 — VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 (October 4, 2002)

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  • 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)