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510(k) K925114

LAPAROSCOPIC INSTRUMENTS by Endo Technic Corp. — Product Code HFI

K925114 is an FDA 510(k) premarket notification submitted by Endo Technic Corp. for the device "LAPAROSCOPIC INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code HFI (Coagulator, Culdoscopic (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Endo Technic Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1994
Date Received
October 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Culdoscopic (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
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)
  • K924058 — TROCAR (March 30, 1993)
  • K914825 — 1-125 ENDOSEED (March 19, 1992)
  • K910200 — LASER-35 (May 9, 1991)
  • K864976 — SOLUSET CALCIUM DEMINERALIZING SOLUTION (February 27, 1987)
  • K862129 — SET CANAL SEALER PASTE (July 22, 1986)

Other clearances for product code HFI

  • K151567 — ENDOPLUS hand-held laparoscopic instruments (December 23, 2015)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K936026 — COOK LAPAROSCOPIC MINI RETRACTOR SET (March 11, 1994)
  • K924148 — DIAMOND-SHARP(R) TROCARS (February 28, 1994)
  • K930571 — REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING (February 1, 1994)
  • K844053 — CANON 60 DEGREE FUNDUS CAMERA CF-60S (December 19, 1984)

FDA data resources