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510(k) K896667

LORENZ STENT by Walter Lorenz Surgical, Inc. — Product Code FWN

K896667 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "LORENZ STENT". The FDA issued a decision of Substantially Equivalent on February 22, 1990. The device falls under product code FWN (Prosthesis, Larynx (Stents And Keels)), a Class II device regulated under 21 CFR 874.3620. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1990
Date Received
November 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Larynx (Stents And Keels)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Walter Lorenz Surgical, Inc.

  • K063386 — LORENZ ORTHODONTIC ANCHORAGE SYSTEM (February 9, 2007)
  • K063052 — LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES (January 12, 2007)
  • K063506 — LORENZ STERNAL CLOSURE SYSTEM (December 18, 2006)
  • K062842 — TWIST DRILL (December 4, 2006)
  • K061384 — LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITAN (June 6, 2006)
  • K042516 — OTOMIMIX (November 8, 2004)
  • K030425 — LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER (May 14, 2004)
  • K040990 — MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS (May 13, 2004)
  • K040983 — LORENZ SELF-DRILLING IMF SCREW (May 5, 2004)
  • K033740 — LORENZ STERNAL CLOSURE SYSTEM (December 15, 2003)

Other clearances for product code FWN

  • K091135 — RUTTER SUPRA STOMAL STENTS (September 14, 2009)
  • K000154 — ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 (March 29, 2000)
  • K962693 — MONTGOMERY RADIOPAQUE LARYNGEAL KEEL (August 9, 1996)
  • K884810 — SILICONE LARYNGEAL STENT (May 10, 1989)
  • K864936 — 'EXMOOR' DAS GUPTA LARYNGEAL KEEL (April 27, 1987)
  • K853726 — LARYNGEAL (March 12, 1986)
  • K842800 — MONTG. LARYNGEAL KEEL (August 2, 1984)
  • K842287 — MONTGOMERY LARYNGEAL STENT (June 27, 1984)
  • K841347 — LARYNGEAL STENT (May 2, 1984)

FDA data resources