Home / 510(k) Clearances / K850634

510(k) K850634

SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS by Surgidyne, Inc. — Product Code GCY

K850634 is an FDA 510(k) premarket notification submitted by Surgidyne, Inc. for the device "SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS". The FDA issued a decision of Substantially Equivalent on June 28, 1985. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Surgidyne, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1985
Date Received
February 19, 1985
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 Surgidyne, Inc.

  • K892334 — LEONARD TUBE (May 31, 1989)
  • K883582 — VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM (October 3, 1988)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • K860030 — SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID (February 12, 1986)
  • K852180 — SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC. (July 1, 1985)

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