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FDA 510(k)

HEM-O-LOCK, MODEL 523935

K-Number: K982944 · 1998-11-19

ApplicantWeck Closure Systems
Decision Date1998-11-19
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEM-O-LOCK, MODEL 523935 is the device name listed in this FDA 510(k) record. The listed applicant is Weck Closure Systems. It received FDA 510(k) clearance on 1998-11-19 under 510(k) number K982944. 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-LOCK, MODEL 523935?

HEM-O-LOCK, MODEL 523935 is a medical device that received FDA 510(k) clearance on 1998-11-19. The listed applicant is Weck Closure Systems. The 510(k) number is K982944.

When did HEM-O-LOCK, MODEL 523935 receive FDA 510(k) clearance?

HEM-O-LOCK, MODEL 523935 received FDA 510(k) clearance on 1998-11-19, under 510(k) number K982944.

Who is the listed applicant for HEM-O-LOCK, MODEL 523935?

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

What is the FDA product code for HEM-O-LOCK, MODEL 523935?

The FDA product code for HEM-O-LOCK, MODEL 523935 is FZP.

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.

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Other records listing Weck Closure Systems 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.

K011660WECK CARDIAC PACING WIRESK003337HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240K993157HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240K982941HEM-O-LOK MODEL NUMBERS 523900, 523970K982313HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS

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 CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

Official Source

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

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