Cleared Traditional

K905471 - TROCAR ACCESS SHEATH

K905471 is the FDA 510(k) clearance for TROCAR ACCESS SHEATH by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K905471 · Cook Ob/Gyn · Obstetrics & Gynecology device
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May 1991
Decision
154d
Days
Class 2
Risk

K905471 is an FDA 510(k) clearance for the TROCAR ACCESS SHEATH. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on May 9, 1991 after a review of 154 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 Cook Ob/Gyn devices

Submission Details

510(k) Number K905471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1990
Decision Date May 09, 1991
Days to Decision 154 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
6d faster than avg
Panel avg: 160d · This submission: 154d
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 K905471.
DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
K914968 · Ethicon, Inc. · Feb 1992
ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF
K912398 · Ethicon, Inc. · Dec 1991
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV
K910921 · United States Surgical, A Division of Tyco Healthc · Aug 1991
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
K904848 · Origin Medsystems, Inc. · Apr 1991
ENDOTHRED ADJUSTABLE STABILITLY THEREAD
K910008 · Ethicon, Inc. · Mar 1991
LAPAROSCOPE
K905196 · Baxter Healthcare Corp · Mar 1991