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

Winston-Salem, NC, US

Wiltek Medical, Inc. appears in FDA device records in Winston-Salem, NC. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 21 510(k) clearances for Wiltek Medical, Inc. between 1989 and 1999. The busiest year on record is 1989, with 11. The most recent is 1999, with 1.

Clearances by year, as a table
510(k) clearance decisions for Wiltek Medical, Inc., by decision year
YearClearances
198911
19915
19922
19931
19941
19991
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K990231WILTEK HOT BIOPSY FORCEPSKGESubstantially Equivalent
K922989WILTEK IRRIGAITON/ASPIRATION TUBE SETBYYSubstantially Equivalent
K930419WILTEK BIOPSY FORCEPSBWHSubstantially Equivalent
K914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETERFGESubstantially Equivalent
K914881WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERFGESubstantially Equivalent
K914132WILTEK ELECTROCAUTERY ACTIVE CORDGEISubstantially Equivalent
K914131WILTEK ELECTROCAUTERY ADAPTORGEISubstantially Equivalent
K912288WILTEK STANDARD CHOLANGIOGRAPHY CATHETERFGESubstantially Equivalent
K912122CHOLANGIOGRAPHY CATHETERFGESubstantially Equivalent
K910334ELECTROCAUTERY PROBEGEISubstantially Equivalent
K894871WILTEK BILIARY STENT SETFGESubstantially Equivalent
K894870WILTEK NASAL BILIARY DRAINAGE SETBSSSubstantially Equivalent
K894869WILTEK POLYPECTOMY SNAREFDISubstantially Equivalent
K894868WILTEK VARICES INJECTION NEEDLEFBKSubstantially Equivalent
K894867WILTEK E.R.C.P. CATHETERFGESubstantially Equivalent
K894866WILTEK STONE EXTRACTORLQRSubstantially Equivalent
K894865WILTEK BALLOON STONE EXTRACTORLQRSubstantially Equivalent
K894863WILTEK CYTOLOGY BRUSHFDXSubstantially Equivalent
K894862WILTEK GRASPING FORCEPSOCZSubstantially Equivalent
K894861WILTEK PAPILLOTOMEKNSSubstantially Equivalent
K894860WILTEK GASTRIC FEEDING TUBEFPDSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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