Home / 510(k) Clearances / K931950

510(k) K931950

POOLE TIP SUCTION PROBE by Mayaguez Medical Center — Product Code GCY

K931950 is an FDA 510(k) premarket notification submitted by Mayaguez Medical Center for the device "POOLE TIP SUCTION PROBE". The FDA issued a decision of Substantially Equivalent on August 11, 1993. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Mayaguez Medical Center has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1993
Date Received
April 20, 1993
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 Mayaguez Medical Center

  • K932804 — IRRIGATING TAPERED PROBE (August 16, 1993)
  • K932805 — 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (August 16, 1993)
  • K932806 — POOLE TIP SUCTION PROBE & TUBING KIT (August 11, 1993)
  • K931854 — ENDOSCOPIC BLUNT DISSECTING INSTRUMENT (August 10, 1993)
  • K931912 — IRRIGATING BLUNT DISSECTOR (August 10, 1993)
  • K931856 — 5.0 MM IRRIGATION/ASPIRATION PROBE (August 10, 1993)
  • K931706 — ENDOSCOPIC CABLE DRAPE (August 6, 1993)
  • K931707 — ENDOSCOPIC CABLE/WIRE COVER (August 6, 1993)
  • K931705 — ENDOSCOPIC INSTRUMENT HOLDER (July 22, 1993)

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)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)

FDA data resources