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510(k) K931548

INAMED DEVELOPMENT ASPIRATION TIP by Inamed Development Co. — Product Code GCX

K931548 is an FDA 510(k) premarket notification submitted by Inamed Development Co. for the device "INAMED DEVELOPMENT ASPIRATION TIP". The FDA issued a decision of Substantially Equivalent on January 10, 1994. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Inamed Development Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1994
Date Received
March 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Inamed Development Co.

  • K904265 — INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER (March 6, 1991)
  • K901742 — INAMED SMALL DRAIN SYSTEM (May 7, 1990)
  • K901764 — INAMED CONVERTIBLE DRAIN SYSTEM (May 7, 1990)
  • K894618 — INAMED RHEMO-D (TM) DILATOR (January 18, 1990)
  • K896491 — INAMED CLOSED-WOUND DRAIN SYSTEM (January 8, 1990)
  • K894073 — INAMED PRO-TEC SILICONE SURGICAL GLOVES (September 18, 1989)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)

FDA data resources