Cleared Traditional

K151567 - ENDOPLUS hand-held laparoscopic instruments

K151567 is an FDA 510(k) clearance for ENDOPLUS hand-held laparoscopic instruments, manufactured by Endoplus. The device is a Class 2 Obstetrics & Gynecology device with product code HFI cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K151567 · Endoplus · Obstetrics & Gynecology device
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Dec 2015
Decision
196d
Days
Class 2
Risk

K151567 is an FDA 510(k) clearance for the ENDOPLUS hand-held laparoscopic instruments. Classified as Coagulator, Culdoscopic (and Accessories) (product code HFI), Class II - Special Controls.

Submitted by Endoplus (Mundelein, US). The FDA issued a Cleared decision on December 23, 2015 after a review of 196 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K151567

510(k) Number K151567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2015
Decision Date December 23, 2015
Days to Decision 196 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 160d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFI Device Classification - Class 2, Special Controls

Product Code HFI Coagulator, Culdoscopic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFI Coagulator, Culdoscopic (and Accessories)

Devices cleared under the same product code (HFI) and FDA review panel - the closest regulatory comparables to K151567.
SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925957 · Zinnanti Surgical Instruments, Inc. · Jun 1994
FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925960 · Zinnanti Surgical Instruments, Inc. · Jun 1994
COOK LAPAROSCOPIC MINI RETRACTOR SET
K936026 · Cook Urological, Inc. · Mar 1994
CANON 60 DEGREE FUNDUS CAMERA CF-60S
K844053 · Canon USA, Inc. · Dec 1984