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510(k) K810636

VARIODRAIN by Colmed, Ltd. — Product Code GCY

K810636 is an FDA 510(k) premarket notification submitted by Colmed, Ltd. for the device "VARIODRAIN". The FDA issued a decision of Substantially Equivalent on May 1, 1981. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Colmed, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1981
Date Received
March 10, 1981
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 Colmed, Ltd.

  • K811209 — JACOB WIRZ TRANSFIXATION PIN (June 16, 1981)
  • K810117 — HALOGEN HEADLIGHT SYSTEM (February 10, 1981)
  • K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT (May 28, 1980)
  • K801006 — CHARNLEY DESIGN HIP PROSTHESIS (May 20, 1980)
  • K800762 — PS3 TITANIUM SCREW DENTAL IMPLANT (May 14, 1980)
  • K792241 — PELIMIT (November 30, 1979)

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