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FDA 510(k)

ENDO-SPONGE

K-Number: K892218 · 1989-05-31

ApplicantEndovations
Decision Date1989-05-31
Product CodeMNL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO-SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Endovations. It received FDA 510(k) clearance on 1989-05-31 under 510(k) number K892218. The device is classified under product code MNL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-SPONGE?

ENDO-SPONGE is a medical device that received FDA 510(k) clearance on 1989-05-31. The listed applicant is Endovations. The 510(k) number is K892218.

When did ENDO-SPONGE receive FDA 510(k) clearance?

ENDO-SPONGE received FDA 510(k) clearance on 1989-05-31, under 510(k) number K892218.

Who is the listed applicant for ENDO-SPONGE?

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

What is the FDA product code for ENDO-SPONGE?

The FDA product code for ENDO-SPONGE is MNL.

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Other records listing Endovations 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.

K955413ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETERK942110INJECT-SNAREK934315ENDOVATIONS(R) .035 PRE-CUT PAPILLATOMEK9138412 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATHK9138705MM MICROSCISSORSK911155OVAL CUP BIOPSY FORCEP

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Related Devices (Code: MNL)

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.

K950689UCBCox Medical Ent., Inc.K946293MILL-ROSE SCOPE CLEANING BRUSHMill-Rose LaboratoryK874239CLEANING BRUSHEndovations

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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