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510(k) K936223

PRESSURE IRRIGATING SYSTEM by Level 1 Technologies, Inc. — Product Code GCY

K936223 is an FDA 510(k) premarket notification submitted by Level 1 Technologies, Inc. for the device "PRESSURE IRRIGATING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 12, 1994. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Level 1 Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1994
Date Received
December 29, 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 Level 1 Technologies, Inc.

  • K942844 — LEVEL 1 BLOOD STREAM RECOVERY SYSTEM (April 26, 1996)
  • K942271 — LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE (July 12, 1995)
  • K911383 — HOTLINE FLUID WARMER (October 17, 1991)
  • K873435 — LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET (October 5, 1987)

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)
  • 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)
  • K933170 — INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (September 16, 1993)

FDA data resources