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510(k) K810370

POLLACK CHAIN CYSOURETHROGRAM SET by Vance Products, Inc. — Product Code FGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1981
Date Received
February 12, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethrographic, Male
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Vance Products, Inc.

  • K820313 — VPI-FAIR URETHRAL STENT (March 1, 1982)
  • K812995 — VANCE-JACOBELLIS MICROHEMATURIA CATHETER (March 1, 1982)
  • K813278 — VPI URETERAL DILATATION BALLON CATHETER (December 18, 1981)
  • K812785 — VANCE-AMBROSE RESECTOSCOPE FORCEPS (November 16, 1981)
  • K812057 — VANCE CYSTOSCOPIC (July 31, 1981)
  • K811833 — VNACE FASCIAL DILATOR SET (July 10, 1981)
  • K811454 — VANCE PROSTATIC ASPIRATION SET (June 9, 1981)
  • K810371 — VANCE URETHAL DILATOR SET (March 20, 1981)
  • K810368 — VANCE PERCUTANEOUS MALECOT NEPHROSTOMY (March 20, 1981)
  • K810367 — KISH URETHRAL ILLUMINATED CATHETER SET (March 20, 1981)

Other clearances for product code FGI

  • K023019 — VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 (December 10, 2002)
  • K013360 — DFINER UROLOGICAL CATHETER (February 20, 2002)