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510(k) K974138

ROCKET ELECTRODE by A & A Medical, Inc. — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1998
Date Received
November 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type

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

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