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510(k) K811833

VNACE FASCIAL DILATOR SET by Vance Products, Inc. — Product Code KOE

K811833 is an FDA 510(k) premarket notification submitted by Vance Products, Inc. for the device "VNACE FASCIAL DILATOR SET". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Vance Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 30, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
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)
  • K811454 — VANCE PROSTATIC ASPIRATION SET (June 9, 1981)
  • K810371 — VANCE URETHAL DILATOR SET (March 20, 1981)
  • K810372 — VANCE DEFLECTABLE BIOPSY BRUSH SET (March 20, 1981)
  • K810367 — KISH URETHRAL ILLUMINATED CATHETER SET (March 20, 1981)
  • K810370 — POLLACK CHAIN CYSOURETHROGRAM SET (March 20, 1981)

Other clearances for product code KOE

  • K191061 — Optilume Basic Urological Balloon Dilation Catheter (January 2, 2020)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (October 10, 1997)
  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K961904 — AQ HYDROPHILIC DILATORS (October 18, 1996)
  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K920551 — 120 FR OPTILUME PROSTATE BALLOON DILATOR (October 28, 1992)
  • K922349 — DOWD(TM) II (August 14, 1992)
  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)

FDA data resources