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)

HEM-O-LOK XL CLIP

K-Number: K030311 · 2003-02-26

ApplicantWeck
Decision Date2003-02-26
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEM-O-LOK XL CLIP is the device name listed in this FDA 510(k) record. The listed applicant is Weck. It received FDA 510(k) clearance on 2003-02-26 under 510(k) number K030311. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEM-O-LOK XL CLIP?

HEM-O-LOK XL CLIP is a medical device that received FDA 510(k) clearance on 2003-02-26. The listed applicant is Weck. The 510(k) number is K030311.

When did HEM-O-LOK XL CLIP receive FDA 510(k) clearance?

HEM-O-LOK XL CLIP received FDA 510(k) clearance on 2003-02-26, under 510(k) number K030311.

Who is the listed applicant for HEM-O-LOK XL CLIP?

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

What is the FDA product code for HEM-O-LOK XL CLIP?

The FDA product code for HEM-O-LOK XL CLIP is FZP.

Other records listing Weck 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.

K021808WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER

Related Devices (Code: FZP)

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.

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

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.

↑