510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ingfertility, LLC

Valleyford, WA, US

Ingfertility, LLC appears in FDA device records in Valleyford, WA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Ingfertility, LLC in 2008.

Clearances by year, as a table
510(k) clearance decisions for Ingfertility, LLC, by decision year
YearClearances
20081
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K072741PRE-VA VAGINAL LUBRICANTPEBSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0626-2009Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids.Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain