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510(k) K040001

STEERABLE STYLET by Synovis Surgical Innovations — Product Code DRB

K040001 is an FDA 510(k) premarket notification submitted by Synovis Surgical Innovations for the device "STEERABLE STYLET". The FDA issued a decision of Substantially Equivalent on March 9, 2004. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Synovis Surgical Innovations has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2004
Date Received
January 2, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Catheter
Device Class
Class II
Regulation Number
870.1380
Review Panel
CV
Submission Type

Other clearances by Synovis Surgical Innovations

  • K122306 — SYNOVIS COLLAGEN MATRIX (TBD) (March 8, 2013)
  • K083039 — VERITAS COLLAGEN MATRIX (DRY) (November 26, 2008)
  • K062915 — VERITAS COLLAGEN MATRIX (December 6, 2006)
  • K041669 — VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD (October 27, 2004)
  • K040415 — PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PE (April 14, 2004)
  • K040119 — PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE L (March 17, 2004)
  • K030879 — VERITAS COLLAGEN MATRIX (April 24, 2003)

Other clearances for product code DRB

  • K220280 — Arrow Stiffening Stylet (August 30, 2022)
  • K191469 — Biotronik Stylets (August 1, 2019)
  • K182660 — GaltTWS (May 30, 2019)
  • K170298 — Liberator Beacon Tip Locking Stylet (October 18, 2017)
  • K142116 — LLD EZ (August 12, 2014)
  • K090163 — STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (April 1, 2009)
  • K080924 — MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (April 30, 2008)
  • K072864 — ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (March 13, 2008)
  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)

FDA data resources