Cleared Traditional

K880991 - LASER OPTICAL CATHETER SYSTEM

K880991 is an FDA 510(k) clearance for LASER OPTICAL CATHETER SYSTEM, manufactured by Medline Industries, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K880991 · Medline Industries, Inc. · Obstetrics & Gynecology device
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May 1988
Decision
78d
Days
Class 2
Risk

K880991 is an FDA 510(k) clearance for the LASER OPTICAL CATHETER SYSTEM. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Englewood, US). The FDA issued a Cleared decision on May 25, 1988 after a review of 78 days - a notably fast clearance 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: 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 - K880991

510(k) Number K880991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date May 25, 1988
Days to Decision 78 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
83d faster than avg
Panel avg: 161d · This submission: 78d
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 45
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K880991.
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MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
K880173 · Cooper Lasersonics, Inc. · Mar 1988
KTP/532 LASER FOR OB-GYN USE
K874837 · Laserscope · Mar 1988
HERACURE LS 500
K875078 · W.C. Heraeus GmbH · Feb 1988
K880991 · LASER OPTICAL CATHETER SYSTEM
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