Home / 510(k) Clearances / K810788

510(k) K810788

SURGICAL TUBE HOLDER by The Urology Group — Product Code FZX

K810788 is an FDA 510(k) premarket notification submitted by The Urology Group for the device "SURGICAL TUBE HOLDER". The FDA issued a decision of Substantially Equivalent on April 17, 1981. The device falls under product code FZX (Guide, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. The Urology Group has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1981
Date Received
March 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by The Urology Group

  • K831703 — COVERUPS (January 3, 1984)
  • K831489 — SURGICAL TUBE HOLDER (December 12, 1983)
  • K810739 — SUCTION WOUND DRAINAGE DEVICE (June 26, 1981)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)
  • K801629 — COVER-ALL MALE INCONTINENCE DEVICE (August 12, 1980)

Other clearances for product code FZX

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • K871413 — CIVCO STEPPER (July 14, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K862564 — A.C.L. GUIDE KIT (August 18, 1986)
  • K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (December 24, 1985)
  • K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER (July 11, 1985)
  • K842698 — BRITISH SPINAL FUSION SET (September 12, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841619 — DRILL GUIDE (July 11, 1984)
  • K841297 — TECHMEDICA DRILL GUIDE (April 25, 1984)

FDA data resources