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)

MEDELA SINGLE USE SILC CUP, MODEL 077.0791

K-Number: K041579 · 2005-04-21

ApplicantMedela AG
Decision Date2005-04-21
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDELA SINGLE USE SILC CUP, MODEL 077.0791 is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2005-04-21 under 510(k) number K041579. The device is classified under product code HDB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDELA SINGLE USE SILC CUP, MODEL 077.0791?

MEDELA SINGLE USE SILC CUP, MODEL 077.0791 is a medical device that received FDA 510(k) clearance on 2005-04-21. The listed applicant is Medela AG. The 510(k) number is K041579.

When did MEDELA SINGLE USE SILC CUP, MODEL 077.0791 receive FDA 510(k) clearance?

MEDELA SINGLE USE SILC CUP, MODEL 077.0791 received FDA 510(k) clearance on 2005-04-21, under 510(k) number K041579.

Who is the listed applicant for MEDELA SINGLE USE SILC CUP, MODEL 077.0791?

The FDA 510(k) record lists Medela AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDELA SINGLE USE SILC CUP, MODEL 077.0791?

The FDA product code for MEDELA SINGLE USE SILC CUP, MODEL 077.0791 is HDB.

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 Medela AG 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.

K251377Magic InBraK223388Invia® Integrated DressingK214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemK191653Freestyle FlexK182191Invia Abdominal Dressing KitK180415Invia White Foam NPWT

View all 23 devices →

Related Devices (Code: HDB)

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.

K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)Clinical Innovations, LLCK043614VACULINK, MODEL VCL 3000Medevco, Inc.K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300Fortune Medical Instrument Corp.K020447MITYVAC MERLIN, MODEL 10027Prism Enterprises, Inc.K013460SWIFT LOW PROFILE CUP (PRO CUP)Swift Delivery ProductsK011532MITYVACPrism Enterprises, 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.

↑