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FDA 510(k)

COTTON ROLLS

K-Number: K802429 · 1980-10-23

ApplicantWorldwide Surgical Gauze
Decision Date1980-10-23
Product CodeEFN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COTTON ROLLS is the device name listed in this FDA 510(k) record. The listed applicant is Worldwide Surgical Gauze. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802429. The device is classified under product code EFN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COTTON ROLLS?

COTTON ROLLS is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Worldwide Surgical Gauze. The 510(k) number is K802429.

When did COTTON ROLLS receive FDA 510(k) clearance?

COTTON ROLLS received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802429.

Who is the listed applicant for COTTON ROLLS?

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

What is the FDA product code for COTTON ROLLS?

The FDA product code for COTTON ROLLS is EFN.

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 Worldwide Surgical Gauze 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.

K823455SURGICAL GAUZEK812572GAUZE SPONGESK803172GAUZE SPONGES

Related Devices (Code: EFN)

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.

K872810STRUNG DENTAL ROLLSAmerican Silk Sutures, Inc.K871464MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STERMedgroup Enterprises, Inc.K863764COTTON ROLLS, NON-STERILEThe Medical Group, Inc.K861338DENTAL COTTON ROLLS, STERILE AND NON-STERILEIntl. Verbandstoff-Fabrik SchaffhauK861727COTTON FILLED GAUZE SPONGES 2 X 2Cross Country Paper Products Corp.K843539TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-Molnlycke A/S Hospital Products

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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