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510(k) K994256

SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 by A & A Medical, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2000
Date Received
December 17, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
  • K974038 — THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPR (May 11, 1998)
  • K974138 — ROCKET ELECTRODE (January 30, 1998)

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