Home / 510(k) Clearances / K843617

510(k) K843617

SDC SILICONE SUMP DRAIN by Science Development Corp. — Product Code GBX

K843617 is an FDA 510(k) premarket notification submitted by Science Development Corp. for the device "SDC SILICONE SUMP DRAIN". The FDA issued a decision of Substantially Equivalent on October 24, 1984. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Science Development Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1984
Date Received
September 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Science Development Corp.

  • K842491 — SDC SILICONE FORCEP SHODS PRODUCT (August 10, 1984)
  • K833355 — SDC VASCULAR TIES (January 27, 1984)
  • K832090 — SCD SKIN TEMP. SENSORS #3400 ETC (October 31, 1983)
  • K832391 — QT-100 ELECTRONIC TEMP. MONITOR (September 12, 1983)
  • K832392 — SDC ORAL-RECTAL TEMP. PROBE (September 12, 1983)
  • K830353 — ESOPHAGEAL PROBE W/TEMP. INDICATOR (April 6, 1983)
  • K830329 — ESOPHAGEAL STETHOSCOPE (March 11, 1983)
  • K830039 — SDC RECTAL TEMP. PROBE PRODUCT #1020 (February 23, 1983)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)

FDA data resources