Cleared Traditional

K903528 - LAPAROSCOPE

K903528 is an FDA 510(k) clearance for LAPAROSCOPE, manufactured by Intramed Laboratories, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K903528 · Intramed Laboratories, Inc. · Obstetrics & Gynecology device
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Sep 1990
Decision
29d
Days
Class 2
Risk

K903528 is an FDA 510(k) clearance for the LAPAROSCOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on September 4, 1990 after a review of 29 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 Intramed Laboratories, Inc. devices

FDA 510(k) Submission Details - K903528

510(k) Number K903528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1990
Decision Date September 04, 1990
Days to Decision 29 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
131d faster than avg
Panel avg: 160d · This submission: 29d
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 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K903528.
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