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FDA 510(k)

APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE

K-Number: K971498 · 1997-05-05

ApplicantApplied Medical Resources
Decision Date1997-05-05
Product CodeEZB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1997-05-05 under 510(k) number K971498. The device is classified under product code EZB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE?

APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is Applied Medical Resources. The 510(k) number is K971498.

When did APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE receive FDA 510(k) clearance?

APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE received FDA 510(k) clearance on 1997-05-05, under 510(k) number K971498.

Who is the listed applicant for APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE?

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

What is the FDA product code for APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE?

The FDA product code for APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE is EZB.

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Related Devices (Code: EZB)

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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