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510(k) K801350

ACUVAC(TM) SUCTION RESERVOIR 400CC AND by Innovative Surgical Products, Inc. — Product Code GCY

K801350 is an FDA 510(k) premarket notification submitted by Innovative Surgical Products, Inc. for the device "ACUVAC(TM) SUCTION RESERVOIR 400CC AND". The FDA issued a decision of Substantially Equivalent on July 14, 1980. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Innovative Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1980
Date Received
June 9, 1980
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 Innovative Surgical Products, Inc.

  • K843041 — HESLIN DISPOS. TUBING SET (November 21, 1984)
  • K840695 — PHACOEMULSIFICATION KITS (May 22, 1984)
  • K840693 — DISPOSABLE SCLERAL GLOBE PLUG (May 22, 1984)
  • K840694 — LENS INSERTION GLIDE (May 9, 1984)
  • K841072 — IRRIGATION, ASPIRATION TUBING SETS (March 29, 1984)
  • K832235 — DISPOSABLE VITRECTOMY HANDPIECE (September 29, 1983)
  • K821496 — DISPOSABLE IRRIGA/ASPIR. SYSTEM (June 22, 1982)
  • K820765 — PLEURAL DRAINAGE RESERVOIR (April 15, 1982)
  • K820680 — DISPOSABLE TUBING SETS (April 9, 1982)
  • K802973 — ISPVAC TM (December 19, 1980)

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