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FDA 510(k)

OPTIPORE SCRUB SPONGE

K-Number: K810200 · 1981-02-13

ApplicantBio Syntec
Decision Date1981-02-13
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

OPTIPORE SCRUB SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Bio Syntec. It received FDA 510(k) clearance on 1981-02-13 under 510(k) number K810200. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIPORE SCRUB SPONGE?

OPTIPORE SCRUB SPONGE is a medical device that received FDA 510(k) clearance on 1981-02-13. The listed applicant is Bio Syntec. The 510(k) number is K810200.

When did OPTIPORE SCRUB SPONGE receive FDA 510(k) clearance?

OPTIPORE SCRUB SPONGE received FDA 510(k) clearance on 1981-02-13, under 510(k) number K810200.

Who is the listed applicant for OPTIPORE SCRUB SPONGE?

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

What is the FDA product code for OPTIPORE SCRUB SPONGE?

The FDA product code for OPTIPORE SCRUB SPONGE is EFQ.

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Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.

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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