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FDA 510(k)

K-SPONGE

K-Number: K897034 · 1990-02-15

ApplicantKatena Products, Inc.
Decision Date1990-02-15
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

K-SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Katena Products, Inc.. It received FDA 510(k) clearance on 1990-02-15 under 510(k) number K897034. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-SPONGE?

K-SPONGE is a medical device that received FDA 510(k) clearance on 1990-02-15. The listed applicant is Katena Products, Inc.. The 510(k) number is K897034.

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

K-SPONGE received FDA 510(k) clearance on 1990-02-15, under 510(k) number K897034.

Who is the listed applicant for K-SPONGE?

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

What is the FDA product code for K-SPONGE?

The FDA product code for K-SPONGE is HOZ.

Related Clinical Trials

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Other records listing Katena Products, 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.

K912576INSTRUMENT WIPE AND CORNEAL SHIELDK781866CANNULA CADDY

Related Devices (Code: HOZ)

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.

K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000Alphamed, Inc.K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, 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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