Cleared Traditional

K904379 - SURGICAL TROCAR AND CANNULA

K904379 is the FDA 510(k) clearance for SURGICAL TROCAR AND CANNULA by Applied Vascular Devices, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K904379 · Applied Vascular Devices, Inc. · Obstetrics & Gynecology device
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Dec 1990
Decision
87d
Days
Class 2
Risk

K904379 is an FDA 510(k) clearance for the SURGICAL TROCAR AND CANNULA. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on December 21, 1990 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Vascular Devices, Inc. devices

Submission Details

510(k) Number K904379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date December 21, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 160d · This submission: 87d
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 151
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K904379.
LAPAROSCOPIC ASPIRATION PROBE
K910340 · Davol, Inc. · Feb 1991
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
V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES
K904143 · Baxter Healthcare Corp · Dec 1990
ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR
K904104 · Ethicon, Inc. · Dec 1990