Cleared Traditional

LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module (K171113) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171113 · Lina Medical Aps · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jan 2018
Decision
265d
Days
Class 2
Risk

K171113 is an FDA 510(k) clearance for the LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Lina Medical Aps (Glostrup, DK). The FDA issued a Cleared decision on January 4, 2018 after a review of 265 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - 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 Lina Medical Aps devices

Submission Details

510(k) Number K171113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2017
Decision Date January 04, 2018
Days to Decision 265 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 160d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
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 Consultant

Emergo Global Consulting, LLC
Jennifer Tribbett

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 93
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K171113.
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Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K172566 · Hologic, Inc. · Sep 2017
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
K161763 · Smith & Nephew, Inc. · Nov 2016
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K152723 · Hologic, Inc. · Nov 2015