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FDA 510(k)

REPAK SURGICAL PACKS

K-Number: K903908 · 1990-10-26

ApplicantRepack Surgical Enterprises, Inc.
Decision Date1990-10-26
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REPAK SURGICAL PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Repack Surgical Enterprises, Inc.. It received FDA 510(k) clearance on 1990-10-26 under 510(k) number K903908. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPAK SURGICAL PACKS?

REPAK SURGICAL PACKS is a medical device that received FDA 510(k) clearance on 1990-10-26. The listed applicant is Repack Surgical Enterprises, Inc.. The 510(k) number is K903908.

When did REPAK SURGICAL PACKS receive FDA 510(k) clearance?

REPAK SURGICAL PACKS received FDA 510(k) clearance on 1990-10-26, under 510(k) number K903908.

Who is the listed applicant for REPAK SURGICAL PACKS?

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

What is the FDA product code for REPAK SURGICAL PACKS?

The FDA product code for REPAK SURGICAL PACKS is KKX.

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 Repack Surgical Enterprises, 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.

K880942REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC)

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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