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FDA 510(k)

STERILE LAPAROTOMY GAUZE SPONGE

K-Number: K862126 · 1986-06-19

ApplicantAnago, Inc.
Decision Date1986-06-19
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

STERILE LAPAROTOMY GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Anago, Inc.. It received FDA 510(k) clearance on 1986-06-19 under 510(k) number K862126. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE LAPAROTOMY GAUZE SPONGE?

STERILE LAPAROTOMY GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1986-06-19. The listed applicant is Anago, Inc.. The 510(k) number is K862126.

When did STERILE LAPAROTOMY GAUZE SPONGE receive FDA 510(k) clearance?

STERILE LAPAROTOMY GAUZE SPONGE received FDA 510(k) clearance on 1986-06-19, under 510(k) number K862126.

Who is the listed applicant for STERILE LAPAROTOMY GAUZE SPONGE?

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

What is the FDA product code for STERILE LAPAROTOMY GAUZE SPONGE?

The FDA product code for STERILE LAPAROTOMY GAUZE SPONGE is EFQ.

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Other records listing Anago, 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.

K925659U.C.E.Z. LENS CLEANER KITK930161ANAGO SPINAL ANESTHESIA TRAYK926590ANAGO DISPOSABLE INSTANT COLD PACKK926137ANAGO FEM-COOL/FEM-COOL PETITEK926589ANAGO WARM PACKK920615ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT

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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

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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