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510(k) K012556

REPROCESSED GUIDEWIRES by Sterilmed, Inc. — Product Code NML

K012556 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED GUIDEWIRES". The FDA issued a decision of Substantially Equivalent on April 29, 2002. The device falls under product code NML (Catheter, Biliary, Reprocessed), a Class II device regulated under 21 CFR 876.5010. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2002
Date Received
August 8, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Biliary, Reprocessed
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

same as "FGE" except being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Sterilmed, Inc.

  • K240826 — Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapo (October 11, 2024)
  • K190478 — Reprocessed ViewFlex™ Xtra ICE Catheter (November 14, 2019)
  • K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (August 15, 2019)
  • K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (April 15, 2019)
  • K161700 — SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D D (November 21, 2016)
  • K161086 — Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed (September 20, 2016)
  • K153006 — Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) (June 23, 2016)
  • K152090 — Reprocessed Steerable Introducer (March 23, 2016)
  • K152134 — Reprocessed Vessel Sealer (January 15, 2016)
  • K150357 — Reprocessed Electrophysiology Diagnostic Catheters (August 27, 2015)

FDA data resources