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510(k) K915867

SOLCOVAC WOUND DRAINAGE SYSTEM by Solco Basle, Inc. — Product Code GCY

K915867 is an FDA 510(k) premarket notification submitted by Solco Basle, Inc. for the device "SOLCOVAC WOUND DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent (kit) on August 14, 1992. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Solco Basle, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
August 14, 1992
Date Received
December 31, 1991
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 Solco Basle, Inc.

  • K913177 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (February 25, 1993)
  • K913247 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (February 25, 1993)
  • K896857 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (April 5, 1990)
  • K896858 — SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM (April 5, 1990)
  • K896203 — SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER (February 1, 1990)
  • K883058 — SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM (October 28, 1988)
  • K872590 — SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM (September 4, 1987)
  • K872157 — HALL VEIN STRIPPER (July 7, 1987)
  • K843821 — SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS (October 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