Cleared Traditional

K903780 - AUTO SUTURE LAPAROSCOPY ACCESSORY KIT

K903780 is the FDA 510(k) clearance for AUTO SUTURE LAPAROSCOPY ACCESSORY KIT by United States Surgical, A Division of Tyco Healthc. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K903780 · United States Surgical, A Division of Tyco Healthc · Obstetrics & Gynecology device
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Oct 1990
Decision
64d
Days
Class 2
Risk

K903780 is an FDA 510(k) clearance for the AUTO SUTURE LAPAROSCOPY ACCESSORY KIT. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on October 23, 1990 after a review of 64 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K903780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date October 23, 1990
Days to Decision 64 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
96d faster than avg
Panel avg: 160d · This submission: 64d
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 165
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K903780.
GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS
K904142 · Baxter Healthcare Corp · Dec 1990
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
K902722 · Davol, Inc. · Nov 1990
CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS
K903560 · Marlo Surgical Technology · Nov 1990
AUTO SUTURE(R) ENDOSCOPIC SCISSORS
K903206 · United States Surgical, A Division of Tyco Healthc · Oct 1990
LAPAROSCOPIC ACCESS SHEATH SET
K903124 · Cook, Inc. · Oct 1990
LAPAROSCOPIC CATHERTER
K903187 · Cook Ob/Gyn · Oct 1990