Home / 510(k) Clearances / K000027

510(k) K000027

INSUFFLATION NEEDLE, MODEL R65-933 by A & A Medical, Inc. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2000
Date Received
January 5, 2000
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 A & A Medical, Inc.

  • K013491 — HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 (November 19, 2001)
  • K013437 — SF SH CATHETER, MODEL R65-945 (November 19, 2001)
  • K003949 — TACKER, MODEL R65-933 (July 25, 2001)
  • K011512 — MMODIFICATION TO LAMINARIA (July 9, 2001)
  • K010510 — BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 (May 16, 2001)
  • K010789 — CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, (April 27, 2001)
  • K010056 — UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 (February 1, 2001)
  • K994256 — SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 (February 3, 2000)
  • K974038 — THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPR (May 11, 1998)
  • K974138 — ROCKET ELECTRODE (January 30, 1998)

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)