Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COTTON FILLED GAUZE SPONGES 2 X 2

K-Number: K861727 · 1986-07-10

ApplicantCross Country Paper Products Corp.
Decision Date1986-07-10
Product CodeEFN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COTTON FILLED GAUZE SPONGES 2 X 2 is the device name listed in this FDA 510(k) record. The listed applicant is Cross Country Paper Products Corp.. It received FDA 510(k) clearance on 1986-07-10 under 510(k) number K861727. 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 FILLED GAUZE SPONGES 2 X 2?

COTTON FILLED GAUZE SPONGES 2 X 2 is a medical device that received FDA 510(k) clearance on 1986-07-10. The listed applicant is Cross Country Paper Products Corp.. The 510(k) number is K861727.

When did COTTON FILLED GAUZE SPONGES 2 X 2 receive FDA 510(k) clearance?

COTTON FILLED GAUZE SPONGES 2 X 2 received FDA 510(k) clearance on 1986-07-10, under 510(k) number K861727.

Who is the listed applicant for COTTON FILLED GAUZE SPONGES 2 X 2?

The FDA 510(k) record lists Cross Country Paper Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COTTON FILLED GAUZE SPONGES 2 X 2?

The FDA product code for COTTON FILLED GAUZE SPONGES 2 X 2 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 Cross Country Paper Products Corp. 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.

K941327CROSSTEX SELF-SEALING STERILIZATION POUCHK844759SURGICAL SCALPEL BLADES & DISPOSABLES

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 SchaffhauK843539TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-Molnlycke A/S Hospital ProductsK841327DENTAL COTTON ROLLSIntl. Verbandstoff-Fabrik Schaffhau

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.

↑