Cleared Traditional

K904143 - V. MUELLER TROCARS/TROCAR SLEEVES & NEE...

K904143 is the FDA 510(k) clearance for V. MUELLER TROCARS/TROCAR SLEEVES & NEE... by Baxter Healthcare Corp. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K904143 · Baxter Healthcare Corp · Obstetrics & Gynecology device
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Dec 1990
Decision
90d
Days
Class 2
Risk

K904143 is an FDA 510(k) clearance for the V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on December 6, 1990 after a review of 90 days - within the typical 510(k) review window.

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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K904143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1990
Decision Date December 06, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
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 145
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K904143.
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
K905426 · United States Surgical, A Division of Tyco Healthc · Feb 1991
ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER
K904907 · Ethicon, Inc. · Jan 1991
INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS
K904173 · Baxter Healthcare Corp · Dec 1990
ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR
K904104 · Ethicon, Inc. · Dec 1990
GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS
K904142 · Baxter Healthcare Corp · Dec 1990
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
K902722 · Davol, Inc. · Nov 1990