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

Mebane, NC, US

SRI Healthcare, LLC appears in FDA device records in Mebane, NC. FDA records list one 510(k) clearance, no PMA records and 4 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
4

FDA records under these names

1 name

FDA records resolved to SRI Healthcare, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Sri Surgical510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for SRI Healthcare, LLC in 2009.

Clearances by year, as a table
510(k) clearance decisions for SRI Healthcare, LLC, by decision year
YearClearances
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K090383SRI LEVEL II SURGICAL GOWNFYASubstantially Equivalent

Registered establishments

FDA registered establishments for SRI Healthcare, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10558921000111202SRI Healthcare, LLC1416 DOGWOOD WAY, MEBANE, NC 27302 US2026
10559541000113384SRI Healthcare, LLC5155 WESTPARK DR SW, ATL, GA 30336 US2026
10655973002805559SRI Healthcare, LLC6024 Century Oaks Dr, CHATTANOOGA, TN 37416 US2026
15276071527607SRI Healthcare, LLC7086 INDUSTRIAL ROW RD., MASON, OH 45040 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2300-2012Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.Distribution of a product that did not meet specifications. (labeling error)Class IITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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