Home / 510(k) Clearances / K882383

510(k) K882383

MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES by CIVCO Medical Instruments Co., Inc. — Product Code DWZ

K882383 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES". The FDA issued a decision of Substantially Equivalent on November 28, 1988. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. CIVCO Medical Instruments Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1988
Date Received
June 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biopsy, Endomyocardial
Device Class
Class II
Regulation Number
870.4075
Review Panel
CV
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 DWZ

  • K252722 — Biopsy Forceps (September 30, 2025)
  • K170726 — Biopsy Forceps (June 2, 2017)
  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K010473 — SPARROWHAWK DISPOSABLE (June 6, 2001)
  • K000409 — MODIFICATION TO T-REX BIOPSY FORCEPS (February 28, 2000)
  • K991486 — ULTRA-CBX (November 5, 1999)
  • K973818 — T-REX BIOPSY FORCEPS (December 16, 1997)
  • K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER (December 16, 1997)
  • K951447 — DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (July 27, 1995)
  • K933235 — CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF (January 6, 1994)

FDA data resources