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)

LAP LOOP

K-Number: K092897 · 2010-02-01

ApplicantMedsys, S.A.
Decision Date2010-02-01
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAP LOOP is the device name listed in this FDA 510(k) record. The listed applicant is Medsys, S.A.. It received FDA 510(k) clearance on 2010-02-01 under 510(k) number K092897. 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 LAP LOOP?

LAP LOOP is a medical device that received FDA 510(k) clearance on 2010-02-01. The listed applicant is Medsys, S.A.. The 510(k) number is K092897.

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

LAP LOOP received FDA 510(k) clearance on 2010-02-01, under 510(k) number K092897.

Who is the listed applicant for LAP LOOP?

The FDA 510(k) record lists Medsys, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAP LOOP?

The FDA product code for LAP LOOP is KNF.

Other records listing Medsys, S.A. 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.

K062968LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIESK023735LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001

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.

↑