Cleared Traditional

K904848 - PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND...

K904848 is an FDA 510(k) clearance for PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND..., manufactured by Origin Medsystems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K904848 · Origin Medsystems, Inc. · Obstetrics & Gynecology device
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Apr 1991
Decision
164d
Days
Class 2
Risk

K904848 is an FDA 510(k) clearance for the PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Origin Medsystems, Inc. (San Mateo, US). The FDA issued a Cleared decision on April 8, 1991 after a review of 164 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 Origin Medsystems, Inc. devices

FDA 510(k) Submission Details - K904848

510(k) Number K904848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1990
Decision Date April 08, 1991
Days to Decision 164 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
4d slower than avg
Panel avg: 160d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 165
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K904848.
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV
K910921 · United States Surgical, A Division of Tyco Healthc · Aug 1991
PUMP VAC PLUS
K910907 · Marlo Surgical Technology · May 1991
TROCAR ACCESS SHEATH
K905471 · Cook Ob/Gyn · May 1991
ENDOTHRED ADJUSTABLE STABILITLY THEREAD
K910008 · Ethicon, Inc. · Mar 1991
FLYNN TISSUE PROBE AND BLUNT DISSECTOR
K910713 · Marlo Surgical Technology · Mar 1991
HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS
K905759 · Marlo Surgical Technology · Mar 1991