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)

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

K-Number: K880942 · 1988-03-21

ApplicantRepack Surgical Enterprises, Inc.
Decision Date1988-03-21
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) 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 1988-03-21 under 510(k) number K880942. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC)?

REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) is a medical device that received FDA 510(k) clearance on 1988-03-21. The listed applicant is Repack Surgical Enterprises, Inc.. The 510(k) number is K880942.

When did REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) receive FDA 510(k) clearance?

REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) received FDA 510(k) clearance on 1988-03-21, under 510(k) number K880942.

Who is the listed applicant for REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC)?

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 PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC)?

The FDA product code for REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) is LRO.

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.

K903908REPAK SURGICAL PACKS

Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

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.

↑