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FDA 510(k)

KARAYA GUM POWDER

K-Number: K770230 · 1977-02-28

ApplicantAtlantic Surgical
Decision Date1977-02-28
Product CodeEZR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARAYA GUM POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Surgical. It received FDA 510(k) clearance on 1977-02-28 under 510(k) number K770230. The device is classified under product code EZR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARAYA GUM POWDER?

KARAYA GUM POWDER is a medical device that received FDA 510(k) clearance on 1977-02-28. The listed applicant is Atlantic Surgical. The 510(k) number is K770230.

When did KARAYA GUM POWDER receive FDA 510(k) clearance?

KARAYA GUM POWDER received FDA 510(k) clearance on 1977-02-28, under 510(k) number K770230.

Who is the listed applicant for KARAYA GUM POWDER?

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

What is the FDA product code for KARAYA GUM POWDER?

The FDA product code for KARAYA GUM POWDER is EZR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Atlantic Surgical 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.

K820167LAMINATED KARAYA GUM WASHERSK772366BAG, DRAINAGEW/ADHESIVE; PROSTHESIS

Related Devices (Code: EZR)

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.

K844341UNITED SKIN BARRIER PASTEHowmedica Corp.K803100STOMAHESIVE PASTE PROTECTIVE SKIN BARRE. R. Squibb & Sons, Inc.K791146COLO-TAPESuburban Ostomy Supply Co., Inc.K761340OSTOMY KARAYA GUM POWDERHowmedica Corp.K761319KARAYA GUM PRODUCTS - PROCESS CHANGEHowmedica Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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