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510(k) K880704

CERULLO SUCTION REGULATOR by Aesculap Instruments Corp. — Product Code GCX

K880704 is an FDA 510(k) premarket notification submitted by Aesculap Instruments Corp. for the device "CERULLO SUCTION REGULATOR". The FDA issued a decision of Substantially Equivalent on March 29, 1988. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Aesculap Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1988
Date Received
February 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Aesculap Instruments Corp.

  • K890182 — PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV (February 28, 1990)
  • K885046 — INSITUCAT VALVE STRIPPER (February 28, 1990)
  • K890443 — CASPAR SCALP CLIP, APPLIER (June 15, 1989)
  • K893121 — ROBOTRAC (TM) RETRACTOR ARM (June 1, 1989)
  • K884057 — ELAN-E DISPOSABLE DRAPE (October 19, 1988)
  • K860016 — AESCULAP BONE MILL (March 19, 1986)
  • K801886 — BURR, DENTAL (August 20, 1980)
  • K801888 — HANDPIECE, DENTAL (August 20, 1980)
  • K801887 — DRILL, DENTAL (August 20, 1980)
  • K792558 — CONTAINER SYSTEM (December 27, 1979)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)

FDA data resources