Search Results
Found 3 results
510(k) Data Aggregation
K Number
K993361Device Name
TUBING EXTENSION SET
Manufacturer
HURRICANE MEDICAL
Date Cleared
2000-01-04
(90 days)
Product Code
MSR
Regulation Number
886.4150Why did this record match?
Applicant Name (Manufacturer) :
HURRICANE MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.
Device Description
The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.
Ask a Question
K Number
K990672Device Name
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
Manufacturer
HURRICANE MEDICAL
Date Cleared
1999-05-18
(77 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HURRICANE MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices are used in ophthalmic surgery to reconstruct the lacrimal outflow system, dacryocystorhinostomy, and other lacrimal system reconstruction.
Device Description
The referenced devices consist of two pieces of the same gauge size and leagues statules. Description: The reterenced devices consist of two pieces of the same from the relations two by frietion fft, gluing, or crimping.
Ask a Question
K Number
K990671Device Name
DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
Manufacturer
HURRICANE MEDICAL
Date Cleared
1999-05-10
(69 days)
Product Code
HOZ
Regulation Number
886.4790Why did this record match?
Applicant Name (Manufacturer) :
HURRICANE MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices are used to remove excess fluid and debris from the surgical area or instrument. Also, placed on the cornea to moisten the cornea and protect the retina from the intense operating light during ophthalmic surgery.
Device Description
Hurricane Medical corneal light shields are manufactured from non-linting hydrophilic polyvinyl alcohol sponge with a pore size of approximately 100 micron.
Hurricane Medical wipes are made from medical grade nonlinting hydrophilic polyvinyl alcohol (PVA) sponge.
Hurricane Medical Eye Sponges and Spears are highly absorbent materials designed for absorption of fluids during eye surgery. Absorbent materials will include hydrocellulose, polyvinyl alcohol, viscose and US-origin cotton.
Hurricane Medical fluid wicks are made from non-linting polyvinyl alcohol (PVA) sponge with a pore size of approximately 100 microns.
Ask a Question
Page 1 of 1