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

Canoga Park, CA, US

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. appears in FDA device records in Canoga Park, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 8 510(k) clearances for National Advanced Endoscopy Devices, Inc. between 1999 and 2017. The busiest year on record is 1999, with 3. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for National Advanced Endoscopy Devices, Inc., by decision year
YearClearances
19993
20082
20101
20151
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K170285AED SinuscopeEOBSubstantially Equivalent
K141515AED HYSTEROSCOPE AND ACCESSORIESHIHSubstantially Equivalent
K102663AED RESECTOSCOPEFJLSubstantially Equivalent
K081553AED BIPOLAR FORCEPS, MODEL 13-1646GEISubstantially Equivalent
K081503AED MONOPOLAR LAP ACCESSORIESGEISubstantially Equivalent
K993689AED CYSTOSCOPEFAJSubstantially Equivalent
K993688AED LAPAROSCOPEGCJSubstantially Equivalent
K991656AED ARTHROSCOPEHRXSubstantially Equivalent

Registered establishments

FDA registered establishments for National Advanced Endoscopy Devices, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20859473000204191NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.22134 SHERMAN WAY, CANOGA PARK, CA 91303 US2026and 36 more, listed in full below

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

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