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510(k) K151567

ENDOPLUS hand-held laparoscopic instruments by Endoplus — Product Code HFI

K151567 is an FDA 510(k) premarket notification submitted by Endoplus for the device "ENDOPLUS hand-held laparoscopic instruments". The FDA issued a decision of Substantially Equivalent on December 23, 2015. The device falls under product code HFI (Coagulator, Culdoscopic (And Accessories)), a Class II device regulated under 21 CFR 884.4160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2015
Date Received
June 10, 2015
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 for product code HFI

  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K936026 — COOK LAPAROSCOPIC MINI RETRACTOR SET (March 11, 1994)
  • K925114 — LAPAROSCOPIC INSTRUMENTS (February 28, 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