Home / 510(k) Clearances / K914825

510(k) K914825

1-125 ENDOSEED by Endo Technic Corp. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1992
Date Received
October 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Endo Technic Corp.

  • K990908 — MILLENNIUM (May 27, 1999)
  • K971459 — DERMALASE (July 18, 1997)
  • K925079 — LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) (August 24, 1994)
  • K930756 — LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE (March 9, 1994)
  • K925114 — LAPAROSCOPIC INSTRUMENTS (February 28, 1994)
  • K924058 — TROCAR (March 30, 1993)
  • K910200 — LASER-35 (May 9, 1991)
  • K864976 — SOLUSET CALCIUM DEMINERALIZING SOLUTION (February 27, 1987)
  • K862129 — SET CANAL SEALER PASTE (July 22, 1986)

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  • K190839 — GammaTile (January 23, 2020)
  • K191324 — CivaDerm (September 20, 2019)
  • K190296 — GammaTile (March 13, 2019)
  • K180515 — GammaTile (July 6, 2018)