Cleared Traditional

K940505 - ARTICULATING LAPAROSCOPIC RETRACOTOR (U...

K940505 is an FDA 510(k) clearance for ARTICULATING LAPAROSCOPIC RETRACOTOR (U..., manufactured by Uresil Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K940505 · Uresil Corp. · Obstetrics & Gynecology device
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Jun 1994
Decision
138d
Days
Class 2
Risk

K940505 is an FDA 510(k) clearance for the ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL). Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 138 days - within the typical 510(k) review window.

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 Uresil Corp. devices

FDA 510(k) Submission Details - K940505

510(k) Number K940505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1994
Decision Date June 21, 1994
Days to Decision 138 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 160d · This submission: 138d
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 174
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K940505.
ZEISS OPMI L STEREO-LAPAROSCOPE
K931478 · Carl Zeiss, Inc. · Sep 1994
SURGIMAT
K926259 · W.O.M. World of Medicine GmbH · Sep 1994
IRRIGATION PUMP AND TUBING SET
K924611 · Marlo Surgical Technology · Jun 1994
DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE
K941334 · Davol, Inc. · Jun 1994
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED
K923260 · Imtec Corp. · Jun 1994
SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS
K940709 · Baxter Healthcare Corp · May 1994