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FDA 510(k)

S3 MEDICATED GAUZE

K-Number: K874219 · 1987-11-23

ApplicantSurgical Specialties, Inc.
Decision Date1987-11-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

S3 MEDICATED GAUZE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties, Inc.. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K874219. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S3 MEDICATED GAUZE?

S3 MEDICATED GAUZE is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Surgical Specialties, Inc.. The 510(k) number is K874219.

When did S3 MEDICATED GAUZE receive FDA 510(k) clearance?

S3 MEDICATED GAUZE received FDA 510(k) clearance on 1987-11-23, under 510(k) number K874219.

Who is the listed applicant for S3 MEDICATED GAUZE?

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

What is the FDA product code for S3 MEDICATED GAUZE?

The FDA product code for S3 MEDICATED GAUZE is FRO. This falls under the Anesthesiology category.

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Other records listing Surgical Specialties, 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.

K932037SUTURE ABSORBABLE- GUTK930826SUTURE NONABSORBABLE - SILKK930825SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLESK932038SUTURE NONABSORBABLE- SILK, POLYESTERK861445S1 CAVITY PACKINGK861443S1 VAGINAL PACKING

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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