Cleared Traditional

K923568 - TROCAR STABILITY THREAD

K923568 is an FDA 510(k) clearance for TROCAR STABILITY THREAD, manufactured by Applied Medical Resources. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 524-day FDA review.

K923568 · Applied Medical Resources · Obstetrics & Gynecology device
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Dec 1993
Decision
524d
Days
Class 2
Risk

K923568 is an FDA 510(k) clearance for the TROCAR STABILITY THREAD. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on December 23, 1993 after a review of 524 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K923568

510(k) Number K923568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date December 23, 1993
Days to Decision 524 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
364d slower than avg
Panel avg: 160d · This submission: 524d
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 177
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K923568.
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ENTREE BLUNT TIP TROCAR AND ADAPTER
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K932072 · Medical Device Inspection Co., Inc. · Jan 1994
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K923636 · Applied Medical Resources · Nov 1993
URESIL LAPAROSCOPIC RETRACTOR
K921417 · Uresil Corp. · Oct 1993
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K922418 · Baxter Healthcare Corp · Jul 1993