Cleared Traditional

K931561 - TROCAR SLEEVE

K931561 is an FDA 510(k) clearance for TROCAR SLEEVE, manufactured by L.A.S.E.R., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K931561 · L.A.S.E.R., Inc. · Obstetrics & Gynecology device
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Feb 1994
Decision
314d
Days
Class 2
Risk

K931561 is an FDA 510(k) clearance for the TROCAR SLEEVE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by L.A.S.E.R., Inc. (Tomball, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 314 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 L.A.S.E.R., Inc. devices

FDA 510(k) Submission Details - K931561

510(k) Number K931561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date February 07, 1994
Days to Decision 314 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 160d · This submission: 314d
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 212
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K931561.
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ENTREE BLUNT TIP TROCAR AND ADAPTER
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JARIT SURGICAL INSTRUMENTS
K932072 · Medical Device Inspection Co., Inc. · Jan 1994
TROCAR STABILITY THREAD
K923568 · Applied Medical Resources · Dec 1993