Cleared Traditional

K903599 - ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N

K903599 is an FDA 510(k) clearance for ESPI DOUBLE-ACTION INSULATED GRASPER, manufactured by Dixon Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K903599 · Dixon Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
70d
Days
Class 2
Risk

K903599 is an FDA 510(k) clearance for the ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Dixon Medical, Inc. (Atlanta, US). The FDA issued a Cleared decision on October 17, 1990 after a review of 70 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 Dixon Medical, Inc. devices

FDA 510(k) Submission Details - K903599

510(k) Number K903599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1990
Decision Date October 17, 1990
Days to Decision 70 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
90d faster than avg
Panel avg: 160d · This submission: 70d
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 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K903599.
CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS
K903560 · Marlo Surgical Technology · Nov 1990
AUTO SUTURE LAPAROSCOPY ACCESSORY KIT
K903780 · United States Surgical, A Division of Tyco Healthc · Oct 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
AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE
K903207 · United States Surgical, A Division of Tyco Healthc · Sep 1990