Cleared Traditional

K910578 - MCLAUGHLIN LAPAROSCOPIC GRASPER

K910578 is an FDA 510(k) clearance for MCLAUGHLIN LAPAROSCOPIC GRASPER, manufactured by Marlo Surgical Technology. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K910578 · Marlo Surgical Technology · Obstetrics & Gynecology device
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Apr 1991
Decision
51d
Days
Class 2
Risk

K910578 is an FDA 510(k) clearance for the MCLAUGHLIN LAPAROSCOPIC GRASPER. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on April 3, 1991 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - 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.

FDA 510(k) Submission Details - K910578

510(k) Number K910578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1991
Decision Date April 03, 1991
Days to Decision 51 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 161d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
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 - HIS Condom

All 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K910578.
CONDOMS (RUBBER CONTRACEPTIVES)
K910284 · Suretex, Ltd. · Jun 1991
CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW
K910550 · Safetex Corp. · Jun 1991
CMI TENDER TOUCH VE #303TT AND 404TT
K910788 · Challenge Mfg., Inc. · May 1991
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · Armkel, LLC · Mar 1991
TP AND DESIGN, CONDOM
K902324 · China National Medicines & Health Prod. I/E Corp. · Mar 1991
POLYURETHANE CONDOM
K902936 · Apex Medical Technologies, Inc. · Mar 1991
K910578 · MCLAUGHLIN LAPAROSCOPIC GRASPER
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