Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODULAP LOOP

K-Number: K121343 · 2013-06-14

ApplicantAtc Technologies, Inc.
Decision Date2013-06-14
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODULAP LOOP is the device name listed in this FDA 510(k) record. The listed applicant is Atc Technologies, Inc.. It received FDA 510(k) clearance on 2013-06-14 under 510(k) number K121343. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULAP LOOP?

MODULAP LOOP is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Atc Technologies, Inc.. The 510(k) number is K121343.

When did MODULAP LOOP receive FDA 510(k) clearance?

MODULAP LOOP received FDA 510(k) clearance on 2013-06-14, under 510(k) number K121343.

Who is the listed applicant for MODULAP LOOP?

The FDA 510(k) record lists Atc Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODULAP LOOP?

The FDA product code for MODULAP LOOP is KNF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Atc Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K010473SPARROWHAWK DISPOSABLEK994319MODULAPK983623MODULAP

Related Devices (Code: KNF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254303KARL STORZ SUPRALOOPKarl Storz SE & CO. KGK250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑