Cleared Traditional

SHARPE ENDOTENACULUM (K915743) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915743 · Paladin Medical, Inc. · Obstetrics & Gynecology device
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May 1993
Decision
514d
Days
Class 2
Risk

K915743 is an FDA 510(k) clearance for the SHARPE ENDOTENACULUM. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on May 20, 1993 after a review of 514 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Paladin Medical, Inc. devices

Submission Details

510(k) Number K915743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date May 20, 1993
Days to Decision 514 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
354d slower than avg
Panel avg: 160d · This submission: 514d
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 78
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K915743.
ENDOPATH RELOADABLE LINEAR CUTTER
K930934 · Ethicon, Inc. · Mar 1994
RETRACTORS AND SCRAPER
K933008 · Baxter Healthcare Corp · Mar 1994
VIDEO ENDOSCOPE SYSTEM
K922418 · Baxter Healthcare Corp · Jul 1993
DAVOL LAPAROSCOPIC DISSECTORS
K920234 · C.R. Bard, Inc. · Feb 1993
AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE
K915331 · United States Surgical, A Division of Tyco Healthc · Sep 1992
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
K915338 · United States Surgical, A Division of Tyco Healthc · Sep 1992