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FDA 510(k)

STERICOVER

K-Number: K853044 · 1985-11-01

ApplicantSterimed, Inc.
Decision Date1985-11-01
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STERICOVER is the device name listed in this FDA 510(k) record. The listed applicant is Sterimed, Inc.. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K853044. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERICOVER?

STERICOVER is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Sterimed, Inc.. The 510(k) number is K853044.

When did STERICOVER receive FDA 510(k) clearance?

STERICOVER received FDA 510(k) clearance on 1985-11-01, under 510(k) number K853044.

Who is the listed applicant for STERICOVER?

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

What is the FDA product code for STERICOVER?

The FDA product code for STERICOVER is IZI.

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 Sterimed, 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.

K900664DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLESK863512DRAPE STERICOVER

Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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