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510(k) K904265

INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER by Inamed Development Co. — Product Code FZW

K904265 is an FDA 510(k) premarket notification submitted by Inamed Development Co. for the device "INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code FZW (Expander, Surgical, Skin Graft), a Class I device regulated under 21 CFR 878.4800. Inamed Development Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1991
Date Received
September 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Expander, Surgical, Skin Graft
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Inamed Development Co.

  • K931548 — INAMED DEVELOPMENT ASPIRATION TIP (January 10, 1994)
  • 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 FZW

  • K080158 — LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM (May 2, 2008)
  • K984448 — BIRCOLL BALLOON DISSECTOR (January 28, 1999)
  • K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (November 14, 1997)
  • K936186 — AESCULAP SKIN GRAFT MESHER (March 10, 1994)
  • K902349 — SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER (September 5, 1990)
  • K883303 — MENTOR RAPID-SPAN (TM) TISSUE EXPANDER (August 26, 1988)
  • K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (December 2, 1987)

FDA data resources