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510(k) K910787

TITANIUM CONNECTOR (2 PART) by Accurate Surgical Instruments Co. — Product Code FKO

K910787 is an FDA 510(k) premarket notification submitted by Accurate Surgical Instruments Co. for the device "TITANIUM CONNECTOR (2 PART)". The FDA issued a decision of Substantially Equivalent on August 15, 1991. The device falls under product code FKO (Catheter, Peritoneal Dialysis, Single Use), a Class II device regulated under 21 CFR 876.5630. Accurate Surgical Instruments Co. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1991
Date Received
February 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal Dialysis, Single Use
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Accurate Surgical Instruments Co.

  • K950042 — SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER (December 15, 1995)
  • K920515 — INSERTION (May 4, 1992)
  • K910786 — TROCAR (FALLER STYLET) (September 19, 1991)
  • K910785 — TITANIUM CATHETER EXTENDER (August 22, 1991)
  • K862046 — SWAN-NECK PERITONEAL DIALYSIS CATHETERS (June 19, 1986)
  • K850214 — STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN (July 26, 1985)
  • K813488 — CATHETER REGULAR (December 31, 1981)
  • K813487 — CATHETER BUBBLE STAND (December 31, 1981)

Other clearances for product code FKO

  • K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS (June 26, 1998)
  • K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR (February 27, 1998)
  • K885037 — AMUKIN 50% - AIRSPRAY(R) (October 19, 1990)
  • K874650 — PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) (December 9, 1987)
  • K872221 — DIALY-NATE SET & DIALY-NATE CATHETER (October 13, 1987)
  • K871730 — MODIFIED USE OF PULL-APART INTRODUCER SET (May 18, 1987)
  • K870472 — ACUTE PERITONEAL DIALYSIS KIT (February 25, 1987)
  • K860155 — PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 (February 14, 1986)
  • K854966 — ACUTE PERITONEAL DIALYSIS CATHETERS (January 9, 1986)
  • K845041 — CAPD STAGED CONNECTOR (February 21, 1985)

FDA data resources