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510(k) K982667

MICROMEDICS NASAL SEPTAL BUTTON by Micromedics, Inc. — Product Code LFB

K982667 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "MICROMEDICS NASAL SEPTAL BUTTON". The FDA issued a decision of Substantially Equivalent on November 24, 1998. The device falls under product code LFB (Button, Nasal Septal), a Class U device. Micromedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1998
Date Received
July 31, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Button, Nasal Septal
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

Other clearances by Micromedics, Inc.

  • K241739 — Endoscopic Applicator, 41 cm (July 15, 2024)
  • K123847 — MALLEABLE TIP ENDOSCOPIC APPLICATOR (January 8, 2013)
  • K122526 — 360 GAS ASSISTED ENDOSCOPIC APPLICATOR (November 16, 2012)
  • K120608 — ENDOSCOPIC APPLICATOR (March 15, 2012)
  • K102563 — SINGLE CANNULA EXTENDED APPLICATOR (March 15, 2011)
  • K100754 — GRAFT DELIVERY SYSTEM MODEL SA-6115 (June 9, 2010)
  • K073401 — EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 (March 14, 2008)
  • K061092 — BAXTER DUPLOSPRAY MIS APPLICATOR (September 13, 2006)
  • K051157 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS (September 1, 2005)
  • K050340 — MICROMEDICS SPHENOID SINUS STENT (April 27, 2005)

Other clearances for product code LFB

  • K131745 — BLOM-SINGER SEPTAL PERFORATION PROSTHESIS (September 17, 2013)
  • K013696 — SILMED NASAL SEPTAL BUTTON (November 28, 2001)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K920994 — HOOD NASAL SEPTAL BUTTON (May 15, 1992)
  • K901366 — INVOTEC SEPTAL BUTTON (June 14, 1990)
  • K871072 — OMEGA NASAL SEPTAL BUTTON (June 8, 1987)
  • K871200 — CUI NASAL SEPTUM BUTTON (April 15, 1987)
  • K862497 — MICROTEK SEPTAL BUTTON (July 14, 1986)
  • K850492 — NASAL SEPTAL BUTTON (March 7, 1985)
  • K822637 — NASAL SEPTAL BUTTONS (September 28, 1982)

FDA data resources