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FDA 510(k)

SPETZLER TI 100 ANEURYSM CLIP

K-Number: K955064 · 1996-10-17

ApplicantElekta Instruments, Inc.
Decision Date1996-10-17
Product CodeHCH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPETZLER TI 100 ANEURYSM CLIP is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instruments, Inc.. It received FDA 510(k) clearance on 1996-10-17 under 510(k) number K955064. The device is classified under product code HCH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPETZLER TI 100 ANEURYSM CLIP?

SPETZLER TI 100 ANEURYSM CLIP is a medical device that received FDA 510(k) clearance on 1996-10-17. The listed applicant is Elekta Instruments, Inc.. The 510(k) number is K955064.

When did SPETZLER TI 100 ANEURYSM CLIP receive FDA 510(k) clearance?

SPETZLER TI 100 ANEURYSM CLIP received FDA 510(k) clearance on 1996-10-17, under 510(k) number K955064.

Who is the listed applicant for SPETZLER TI 100 ANEURYSM CLIP?

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

What is the FDA product code for SPETZLER TI 100 ANEURYSM CLIP?

The FDA product code for SPETZLER TI 100 ANEURYSM CLIP is HCH.

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Other records listing Elekta Instruments, 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.

K983678ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEK941823LEKSELL NEURO GENERATOR AND ACCESSORIESK946165CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEMK943468LEKSELL SURGIPLANK932261ES-100 ACCESSORIESK925360ES-100 POWER SYSTEM, ES-100 SERIES

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Related Devices (Code: HCH)

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.

K211183Sugita AVM MicroclipsMizuho America, Inc.K180757D-Clip; D-Clip ApplierPeter Lazic GmbHK091921CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIPCodman & Shurtleff, Inc.K081640GIMMI ANEURYSM CLIPS AND APPLYING FORCEPSGimmi GmbHK081489L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERSPeter Lazic GmbHK060915KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERSKirwan Surgical Products, 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.

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