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FDA 510(k)

MAGNETIC POINT GUARD FOR SURGICAL NEEDLES

K-Number: K920706 · 1993-05-26

ApplicantRetrax
Decision Date1993-05-26
Product CodeFHQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAGNETIC POINT GUARD FOR SURGICAL NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Retrax. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K920706. The device is classified under product code FHQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNETIC POINT GUARD FOR SURGICAL NEEDLES?

MAGNETIC POINT GUARD FOR SURGICAL NEEDLES is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Retrax. The 510(k) number is K920706.

When did MAGNETIC POINT GUARD FOR SURGICAL NEEDLES receive FDA 510(k) clearance?

MAGNETIC POINT GUARD FOR SURGICAL NEEDLES received FDA 510(k) clearance on 1993-05-26, under 510(k) number K920706.

Who is the listed applicant for MAGNETIC POINT GUARD FOR SURGICAL NEEDLES?

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

What is the FDA product code for MAGNETIC POINT GUARD FOR SURGICAL NEEDLES?

The FDA product code for MAGNETIC POINT GUARD FOR SURGICAL NEEDLES is FHQ.

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Related Devices (Code: FHQ)

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.

K974327WINGED NEEDLE HOLDERPhx Technologies Corp.K924196LAPAROSCOPIC NEEDLE HOLDERNusurg, Inc.K930330ENDOSCOPIC NEEDLEHOLDER, MODIFICATIONHolmed Corp.K85177925-100,25-220 VARIOUS NEEDLE HOLDERSArtiberiaK85178025-230 TO 25-390 VARIOUS NEEDLE HOLDERSArtiberiaK771859NEEDLE HOLDER, MICROVASCULAREdward Weck, 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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