Home / 510(k) Clearances / K896491

510(k) K896491

INAMED CLOSED-WOUND DRAIN SYSTEM by Inamed Development Co. — Product Code GCY

K896491 is an FDA 510(k) premarket notification submitted by Inamed Development Co. for the device "INAMED CLOSED-WOUND DRAIN SYSTEM". The FDA issued a decision of Substantially Equivalent on January 8, 1990. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Inamed Development Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1990
Date Received
November 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type

Other clearances by Inamed Development Co.

  • K931548 — INAMED DEVELOPMENT ASPIRATION TIP (January 10, 1994)
  • 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)
  • K894073 — INAMED PRO-TEC SILICONE SURGICAL GLOVES (September 18, 1989)

Other clearances for product code GCY

  • K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM (October 1, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)

FDA data resources