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510(k) K182664

FiXcision by Agency For Medical Innovations GmbH — Product Code KOA

K182664 is an FDA 510(k) premarket notification submitted by Agency For Medical Innovations GmbH for the device "FiXcision". The FDA issued a decision of Substantially Equivalent on December 7, 2018. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. Agency For Medical Innovations GmbH has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2018
Date Received
September 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Agency For Medical Innovations GmbH

  • K212659 — More-Cell-System (November 10, 2021)
  • K182013 — EasyInstruments (March 11, 2019)
  • K150718 — Wi-3 HAL-RAR System (June 12, 2015)
  • K092821 — TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 (February 1, 2010)

Other clearances for product code KOA

  • K950267 — URETHRAL SUTURE GUIDE (January 31, 1995)
  • K932465 — LI VASECTOMY (March 2, 1994)
  • K921546 — VASOVASOSTOMY SET (July 2, 1993)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)
  • K921304 — DDV LIGATOR (October 5, 1992)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K921228 — BENDEREV PROTECT-A-PASS NEEDLE (September 14, 1992)
  • K922192 — VAS DILATOR (August 7, 1992)
  • K896058 — GRASPING FORCEPS (December 28, 1989)
  • K891352 — MARLOW ANAL SPECULUM (June 23, 1989)

FDA data resources