ENDOPLUS hand-held laparoscopic instruments— 510(k) K151567

Name: FDA 510(k) clearance K151567
Creator: U.S. Food and Drug Administration
Published: 2015-12-23

Substantially Equivalent

Endoplus

FDA 510(k) clearance K151567 for ENDOPLUS hand-held laparoscopic instruments, Substantially Equivalent on 2015-12-23. Applicant: Endoplus. Device class: 2.

Clearance details

Applicant: Endoplus
Product code: Code HFI
Device class: Class 2
Regulation: 21 CFR 884.4160
Advisory panel: Obstetrics/Gynecology
Date received: 2015-06-10
Decision date: 2015-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HFI

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K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE1994-06-07
K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE1994-06-07
K936026 — COOK LAPAROSCOPIC MINI RETRACTOR SET1994-03-11
K924148 — DIAMOND-SHARP(R) TROCARS1994-02-28
K925114 — LAPAROSCOPIC INSTRUMENTS1994-02-28

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