Cleared Traditional

K874615 - LASER CANNISTER FILTER

K874615 is an FDA 510(k) clearance for LASER CANNISTER FILTER, manufactured by Medical Marketing, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K874615 · Medical Marketing, Inc. · Obstetrics & Gynecology device
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Jun 1988
Decision
227d
Days
Class 2
Risk

K874615 is an FDA 510(k) clearance for the LASER CANNISTER FILTER. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Medical Marketing, Inc. (Fischer, US). The FDA issued a Cleared decision on June 23, 1988 after a review of 227 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4550 - 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. Standard predicate reliance. 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 Medical Marketing, Inc. devices

FDA 510(k) Submission Details - K874615

510(k) Number K874615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date June 23, 1988
Days to Decision 227 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
67d slower than avg
Panel avg: 160d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHR Device Classification - Class 2, Special Controls

Product Code HHR Laser, Surgical, Gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4550
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 - HHR Laser, Surgical, Gynecologic

All 24
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K874615.
ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES
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K870841 · Directed Energy, Inc. · Feb 1988