FDA 510(k)

COTOLIN DRAIN SPONGE AND DRESSING SPONGE

K-Number: K894505 · 1989-09-15

Decision Date1989-09-15

Product CodeEFQ

DecisionSubstantially Equivalent

Device Summary

COTOLIN DRAIN SPONGE AND DRESSING SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is James River Corp.. It received FDA 510(k) clearance on 1989-09-15 under 510(k) number K894505. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COTOLIN DRAIN SPONGE AND DRESSING SPONGE?

COTOLIN DRAIN SPONGE AND DRESSING SPONGE is a medical device that received FDA 510(k) clearance on 1989-09-15. The listed applicant is James River Corp.. The 510(k) number is K894505.

When did COTOLIN DRAIN SPONGE AND DRESSING SPONGE receive FDA 510(k) clearance?

COTOLIN DRAIN SPONGE AND DRESSING SPONGE received FDA 510(k) clearance on 1989-09-15, under 510(k) number K894505.

Who is the listed applicant for COTOLIN DRAIN SPONGE AND DRESSING SPONGE?

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

What is the FDA product code for COTOLIN DRAIN SPONGE AND DRESSING SPONGE?

The FDA product code for COTOLIN DRAIN SPONGE AND DRESSING SPONGE is EFQ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing James River Corp. as applicant

K894147VISULIN TRANSPARENT ADHESIVE DRESSING K893939ISOLATION MASKS K894034MODIFIED LABELING OF SURGICAL GLOVES K892580CARETOUCH EXAMINATION GLOVES K890459JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES K883802CARETEX CENTRAL SUPPLY WRAP

View all 15 devices →

Related Devices (Code: EFQ)

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong Industries K991215SYMTEX 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 Industries K984187CROSSTEX 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.