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FDA 510(k)

ATRAUCLIP (TITANIUM HEMOSTATIC CLIP)

K-Number: K896997 · 1990-02-13

ApplicantS.P.K. Technology, Inc.
Decision Date1990-02-13
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRAUCLIP (TITANIUM HEMOSTATIC CLIP) is the device name listed in this FDA 510(k) record. The listed applicant is S.P.K. Technology, Inc.. It received FDA 510(k) clearance on 1990-02-13 under 510(k) number K896997. 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 ATRAUCLIP (TITANIUM HEMOSTATIC CLIP)?

ATRAUCLIP (TITANIUM HEMOSTATIC CLIP) is a medical device that received FDA 510(k) clearance on 1990-02-13. The listed applicant is S.P.K. Technology, Inc.. The 510(k) number is K896997.

When did ATRAUCLIP (TITANIUM HEMOSTATIC CLIP) receive FDA 510(k) clearance?

ATRAUCLIP (TITANIUM HEMOSTATIC CLIP) received FDA 510(k) clearance on 1990-02-13, under 510(k) number K896997.

Who is the listed applicant for ATRAUCLIP (TITANIUM HEMOSTATIC CLIP)?

The FDA 510(k) record lists S.P.K. Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATRAUCLIP (TITANIUM HEMOSTATIC CLIP)?

The FDA product code for ATRAUCLIP (TITANIUM HEMOSTATIC CLIP) is FZP.

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Other records listing S.P.K. Technology, 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.

K896998ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)

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

View on FDA Database →

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

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