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510(k) K854911

PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) by Angiomed U.S., Inc. — Product Code GBO

K854911 is an FDA 510(k) premarket notification submitted by Angiomed U.S., Inc. for the device "PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code GBO (Catheter, Nephrostomy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Angiomed U.S., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
December 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Angiomed U.S., Inc.

  • K874771 — ANGIOMED INTRODUCING SETS (January 12, 1988)
  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT (January 30, 1987)
  • K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS (October 24, 1986)
  • K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE (September 29, 1986)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K854910 — ANGIOFLOW (July 17, 1986)
  • K854912 — ANGIOMED GUIED WIRES (April 16, 1986)
  • K854908 — UROFLEX (March 14, 1986)
  • K855076 — ANGIOMED URETER DIATION SETS (March 11, 1986)

Other clearances for product code GBO

  • K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETE (August 19, 2004)
  • K021632 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKIN (June 13, 2002)
  • K912109 — URESIL GENERAL PURPOSE DRAINAGE CATHETER (August 12, 1991)
  • K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) (January 24, 1986)
  • K854909 — PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS (January 24, 1986)
  • K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO) (January 24, 1986)
  • K854907 — PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) (January 24, 1986)
  • K820867 — PERCUTANEOUS NEPHROSTOMY SET (April 13, 1982)
  • K781664 — SILASTIC NEPHROSTOMY SYSTEM (January 22, 1979)
  • K781526 — SILASTIC U-TUBE KIT (September 20, 1978)

FDA data resources