510(K) for ptosis sling - What is 510(K) exempt?

C

Cinti

#1
We are manufacturing ptosis sling. It is used to repair eye lid.

We would like to get 510(K) for this product. We understood from FDA website that BD Ophthalmic system had got and their number is K942402. But database haven't showed the details. Kindly help me to locate the details.

[FONT=verdana,arial]What is 510(K) exempt? Is it meant there is no need to apply for 510(K). Kindly clarify.[/FONT]

Usha
 
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Ajit Basrur

Staff member
Admin
#3
Re: 510(K) for ptosis sling

On another note, Product code HNM is for needle, ophthalmic suturing and is 510 (k) exempt.

Is this your product too ? Can you give the correct device name ?
 
M

MIREGMGR

#4
We understood from FDA website that BD Ophthalmic system had got and their number is K942402. But database haven't showed the details. Kindly help me to locate the details.
510(k) content other than the Summary or Statement plus some other high-level information is not available from FDA.

You might want to study how the 510(k) process works, starting at www.fda.gov/cdrh .

I don't know why BD Ophthalmic (or Visitec?) has a 510(k) number for their product, if HNM in fact is the correct Product Code. HNM clearly is Class I, and as Ajit noted, 510(k) exempt.
 
C

Cinti

#5
Dear all,

Thank you very much for your replies. We are manufacturing ptosis sling. It is used for Frontalis Suspension in patients with significant ptosis and poor levator function.

If it come under 510(K) exempt device, kindly let me know the procedure for notifying it in FDA.

Usha
 
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