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510(k) K832068

CODY SACCULOTOMY TACK by Micromedics, Inc. — Product Code ESX

K832068 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "CODY SACCULOTOMY TACK". The FDA issued a decision of Substantially Equivalent on October 19, 1983. The device falls under product code ESX (Tack, Sacculotomy (Cody Tack)), a Class II device regulated under 21 CFR 874.3760. Micromedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1983
Date Received
June 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tack, Sacculotomy (Cody Tack)
Device Class
Class II
Regulation Number
874.3760
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)

FDA data resources