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510(k) K871413

CIVCO STEPPER by CIVCO Medical Instruments Co., Inc. — Product Code FZX

K871413 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "CIVCO STEPPER". The FDA issued a decision of Substantially Equivalent on July 14, 1987. The device falls under product code FZX (Guide, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. CIVCO Medical Instruments Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1987
Date Received
April 8, 1987
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 CIVCO Medical Instruments Co., Inc.

  • K231783 — VitroPRO (November 14, 2023)
  • K222052 — VitroPRO (November 22, 2022)
  • K211270 — CIV-Clear cover (September 13, 2021)
  • K163313 — ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Pro (June 9, 2017)
  • K160806 — Verza Guidance System (August 5, 2016)
  • K131161 — EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MI (September 17, 2013)
  • K131528 — NON-PYROGENIC ULTRASOUND TRANSDUCER COVER (June 11, 2013)
  • K080072 — MRI PATIENT POSITIONING DEVICES (June 4, 2008)
  • K013721 — SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER (December 28, 2001)
  • K002546 — CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE (October 31, 2000)

Other clearances for product code FZX

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • 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)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)

FDA data resources