Cleared Traditional

LiNA OperaScope Needle (K221085) - FDA 510(k) Clearance

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

K221085 · Lina Medical Aps · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
142d
Days
Class 2
Risk

K221085 is an FDA 510(k) clearance for the LiNA OperaScope Needle. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Lina Medical Aps (Glostrup, DK). The FDA issued a Cleared decision on September 2, 2022 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 876.1500 - 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 K221085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2022
Decision Date September 02, 2022
Days to Decision 142 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
18d faster than avg
Panel avg: 160d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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

MEDIcept, Inc.
Scott Blood

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 - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 35
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K221085.
Disposable Injection Needle AF series
K230925 · Alton (Shanghai) Medical Instruments Co., Ltd. · Sep 2023
Sclerotherapy & Endoscopic Needles
K222006 · G-Flex Europe Sprl · Apr 2023
CORE-INJECTOR
K221054 · Incore Co., Ltd. · Dec 2022
Disposable Endoscope Injection Needle
K220292 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Aug 2022
Injection Needle
K213914 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Jul 2022
Endoscopic Injection Needle
K213239 · Beijing Zksk Technology Co., Ltd. · Jun 2022