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510(k) K240763

FirstFit Surgical Kit by Freudenberg Medical, LLC — Product Code EWL

K240763 is an FDA 510(k) premarket notification submitted by Freudenberg Medical, LLC for the device "FirstFit Surgical Kit". The FDA issued a decision of Substantially Equivalent on December 18, 2024. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. Freudenberg Medical, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2024
Date Received
March 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Laryngeal (Taub)
Device Class
Class II
Regulation Number
874.3730
Review Panel
EN
Submission Type

Other clearances by Freudenberg Medical, LLC

  • K192422 — Steerable Introducer 12F (October 4, 2019)
  • K191190 — Steerable Introducer (August 1, 2019)

Other clearances for product code EWL

  • K141380 — PROVOX FREEHANDS FLEXIVOICE (September 26, 2014)
  • K131947 — PROVOX VEGA PUNCTURE SET (October 18, 2013)
  • K092593 — PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (October 14, 2010)
  • K093258 — BLOM-SINGER INDWELLING TEP OCCLUDER (March 3, 2010)
  • K090455 — PROVOX VEGA, MODEL 8130-8135 (June 5, 2009)
  • K082206 — BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-20 (September 4, 2008)
  • K043138 — PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 (November 22, 2004)
  • K022125 — PROVOX FREEHANDS HME, MODEL 7710 (July 30, 2002)
  • K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (June 25, 1999)
  • K974132 — VOICE MASTER PROSTHESIS (February 25, 1998)

FDA data resources