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FDA 510(k)

OGDEN ANCHOR

K-Number: K950875 · 1995-07-11

ApplicantAmerican Medical Electronics, Inc.
Decision Date1995-07-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OGDEN ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Electronics, Inc.. It received FDA 510(k) clearance on 1995-07-11 under 510(k) number K950875. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OGDEN ANCHOR?

OGDEN ANCHOR is a medical device that received FDA 510(k) clearance on 1995-07-11. The listed applicant is American Medical Electronics, Inc.. The 510(k) number is K950875.

When did OGDEN ANCHOR receive FDA 510(k) clearance?

OGDEN ANCHOR received FDA 510(k) clearance on 1995-07-11, under 510(k) number K950875.

Who is the listed applicant for OGDEN ANCHOR?

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

What is the FDA product code for OGDEN ANCHOR?

The FDA product code for OGDEN ANCHOR is HWC. This falls under the Cardiovascular category.

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Other records listing American Medical Electronics, 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.

K951232EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MMK952348OGDEN ANCHORK951545OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONSK951493OGDEN ANCHORK941029OGDEN ANCHOR-SMALL (TENTATIVE)K931381AME UNIVERSAL FIXATION SYSTEM

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Related Devices (Code: HWC)

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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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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