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510(k) K974038

THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT by A & A Medical, Inc. — Product Code JCX

K974038 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT". The FDA issued a decision of Substantially Equivalent on May 11, 1998. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1998
Date Received
October 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
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)
  • K000027 — INSUFFLATION NEEDLE, MODEL R65-933 (April 3, 2000)
  • K994256 — SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 (February 3, 2000)
  • K974138 — ROCKET ELECTRODE (January 30, 1998)

Other clearances for product code JCX

  • K250964 — Protable Phlegm Suction Unit (JMA D01) (May 11, 2026)
  • K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) (June 13, 2025)
  • K251111 — Cary (May 7, 2025)
  • K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (December 2, 2024)
  • K233428 — Easycess Aspiration Pump (November 3, 2023)
  • K222552 — 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specime (December 9, 2022)
  • K182950 — Acare Suction Unit (August 23, 2019)
  • K190789 — IntelliCartTM System (April 24, 2019)
  • K190105 — ZOOM Aspiration Pump (February 21, 2019)
  • K180115 — TWBM Pump (July 24, 2018)

FDA data resources