Cleared Traditional

K904907 - ENDOPATH DISPOSABLE SURGICAL TROCAR RED...

K904907 is the FDA 510(k) clearance for ENDOPATH DISPOSABLE SURGICAL TROCAR RED... by Ethicon, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K904907 · Ethicon, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
85d
Days
Class 2
Risk

K904907 is an FDA 510(k) clearance for the ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER. 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 January 24, 1991 after a review of 85 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 Ethicon, Inc. devices

Submission Details

510(k) Number K904907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1990
Decision Date January 24, 1991
Days to Decision 85 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
75d faster than avg
Panel avg: 160d · This submission: 85d
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 K904907.
LAPAROSCOPE
K905196 · Baxter Healthcare Corp · Mar 1991
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
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