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510(k) K913772

PRESSURE GUARD by Beacon Laboratories, Inc. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1991
Date Received
August 23, 1991
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 Beacon Laboratories, Inc.

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  • K922289 — SESQUIPOLAR(TM) MIS ELECTRODE (January 15, 1993)
  • K925619 — DISPOSABLE HAND-SWITCHING ESU PENCIL (December 24, 1992)
  • K915788 — MIS ELECTROSURGICAL ELECTRODES (March 13, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K905752 — ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE (July 22, 1991)
  • K904506 — ACTIVE ADAPTER (December 13, 1990)
  • K902996 — ARGON BEAM LAPAROSCOPIC ELECTRODE (November 21, 1990)

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  • 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)