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

Mchenry, IL, US

American Endoscopy, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(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
19
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 19 510(k) clearances for American Endoscopy, Inc. between 1982 and 1985. The busiest year on record is 1982, with 12. The most recent is 1985, with 1.

Clearances by year, as a table
510(k) clearance decisions for American Endoscopy, Inc., by decision year
YearClearances
198212
19832
19844
19851
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K853274AMERICAN DILATATION SYSTEMKNQSubstantially Equivalent
K841384PROXIMA 1 PH MONITORFFTSubstantially Equivalent
K833491ENDO BITE BLOCKKTISubstantially Equivalent
K840818BIOPSY FORCEPSFCLSubstantially Equivalent
K833859TAMPONADE BALLOON CUFFGCPSubstantially Equivalent
K833492PERCUTANEOUS ENDOSCOPIC GASTROSCOPYKNTSubstantially Equivalent
K832458AUTOMATIC ENDOSCOPENVESubstantially Equivalent
K821818RETRIEVAL BALLOONSKODSubstantially Equivalent
K821819PIGTAIL STENTSFGESubstantially Equivalent
K822062BALL TIP COAGULATING ELECTRODESGEISubstantially Equivalent
K821817PIGTAIL NASAL CATHETERSFGESubstantially Equivalent
K822061LAVAGING CATHETERSOCXSubstantially Equivalent
K821697INJECTION ASPIRATING NEEDLESGAASubstantially Equivalent
K820431E.R.C.P. CANNULASODDSubstantially Equivalent
K820430DIATHERMIC SNARESKNSSubstantially Equivalent
K820429SPIRAL STONE AND RETRIEVAL BASKETSOCZSubstantially Equivalent
K820240PAPILLOTOMESKNSSubstantially Equivalent
K820239RETRIEVAL FORCEPSKODSubstantially Equivalent
K820259STERILE CYTOLOGY BRUSHESGEESubstantially 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