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

Pine Level, NC, US

CUSTOM ASSEMBLIES, INC. appears in FDA device records in Pine Level, NC. FDA records list one 510(k) clearance, no PMA records and one registered establishment. 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
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Custom Assemblies Inc in 2000.

Clearances by year, as a table
510(k) clearance decisions for Custom Assemblies Inc, by decision year
YearClearances
20001
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K993463INTRAVASCULAR ADMINISTRATION SETFPASubstantially Equivalent

Registered establishments

FDA registered establishments for Custom Assemblies Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10633823000718854CUSTOM ASSEMBLIES, INC.330 EAST MAIN STREET, PINE LEVEL, NC 27568 US2026and 5 more, listed in full below

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-3059-2017Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy TrayThe firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.Class IITerminated

Verification record

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