Cleared Traditional

K912398 - ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIE...

K912398 is the FDA 510(k) clearance for ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIE... by Ethicon, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K912398 · Ethicon, Inc. · Obstetrics & Gynecology device
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Dec 1991
Decision
207d
Days
Class 2
Risk

K912398 is an FDA 510(k) clearance for the ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 17, 1991 after a review of 207 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K912398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1991
Decision Date December 17, 1991
Days to Decision 207 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 160d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 150
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K912398.
TROCAR SHEATH ANCHOR
K915116 · Origin Medsystems, Inc. · Jun 1992
SOF-FLEX LAPAROSCOPIC BASKET
K913299 · Cook Ob/Gyn · Feb 1992
DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
K914968 · Ethicon, Inc. · Feb 1992
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV
K910921 · United States Surgical, A Division of Tyco Healthc · Aug 1991
TROCAR ACCESS SHEATH
K905471 · Cook Ob/Gyn · May 1991
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
K904848 · Origin Medsystems, Inc. · Apr 1991