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FDA 510(k)

LACTOSORB ETHMOID STENT

K-Number: K002131 · 2001-04-13

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2001-04-13
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LACTOSORB ETHMOID STENT is the device name listed in this FDA 510(k) record. The listed applicant is Walter Lorenz Surgical, Inc.. It received FDA 510(k) clearance on 2001-04-13 under 510(k) number K002131. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LACTOSORB ETHMOID STENT?

LACTOSORB ETHMOID STENT is a medical device that received FDA 510(k) clearance on 2001-04-13. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K002131.

When did LACTOSORB ETHMOID STENT receive FDA 510(k) clearance?

LACTOSORB ETHMOID STENT received FDA 510(k) clearance on 2001-04-13, under 510(k) number K002131.

Who is the listed applicant for LACTOSORB ETHMOID STENT?

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

What is the FDA product code for LACTOSORB ETHMOID STENT?

The FDA product code for LACTOSORB ETHMOID STENT is LYA.

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Other records listing Walter Lorenz Surgical, 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.

K063386LORENZ ORTHODONTIC ANCHORAGE SYSTEMK063052LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATESK063506LORENZ STERNAL CLOSURE SYSTEMK062842TWIST DRILLK061384LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUMK042516OTOMIMIX

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Related Devices (Code: LYA)

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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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