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510(k) K901764

INAMED CONVERTIBLE DRAIN SYSTEM by Inamed Development Co. — Product Code GCY

K901764 is an FDA 510(k) premarket notification submitted by Inamed Development Co. for the device "INAMED CONVERTIBLE DRAIN SYSTEM". The FDA issued a decision of Substantially Equivalent on May 7, 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
May 7, 1990
Date Received
April 18, 1990
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)
  • 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 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