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

Mchenry, IL, US

Aspen Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 55 510(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
55
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 55

FDA records hold 55 510(k) clearances for Aspen Laboratories, Inc. between 1976 and 1998. The busiest year on record is 1980, with 12. The most recent is 1998, with 1.

Clearances by year, as a table
510(k) clearance decisions for Aspen Laboratories, Inc., by decision year
YearClearances
19761
19771
19785
19791
198012
19816
19833
19842
19854
19864
19874
19902
19921
19931
19941
19953
19963
19981
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K981220SYSTEM 7500 ABC ELECTROSURGICAL UNITGEISubstantially Equivalent
K963088SHEATH, ELECTROSURGICAL PENCILGEISubstantially Equivalent
K955834SYSTEM 6500 ABC ELECTROSURGICAL UNITGEISubstantially Equivalent
K9602964000 ETMGEISubstantially Equivalent
K953081BEAMER PLUSGEISubstantially Equivalent
K953007EXCALIBUR PLUS ELECTROSURGICAL UNITGEISubstantially Equivalent
K946104SMOKIEVAC ELECTROSURGICAL PENCILGEISubstantially Equivalent
K944012ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATORGEISubstantially Equivalent
K924960EXCALIBUR ELECTROSURGICAL UNITGEISubstantially Equivalent
K913213SINGLE USE LEE ELECTRODEHGISubstantially Equivalent
K896838BISTAT ELECTROSURGICAL UNIT 60-5400-001GEXSubstantially Equivalent
K896839MF-450 ELECTROSURGICAL UNIT 60-5500-001GEISubstantially Equivalent
K872868ASPEN ESMARK BANDAGEFQMSubstantially Equivalent
K872661RGB CAMERA SYSTEMFWFSubstantially Equivalent
K871648TMJ CANNULA SETDZISubstantially Equivalent
K870784A.T.S. 1500 TOURNIQUETKCYSubstantially Equivalent
K863590UNIVERSAL CANNULA SYSTEMHRXSubstantially Equivalent
K862564A.C.L. GUIDE KITFZXSubstantially Equivalent
K854751ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCEEQHSubstantially Equivalent
K860463SINGLE AND DUAL TOURNIQUET CUFFKCYSubstantially Equivalent
K854281MAGNETIC RETRIEVERSubstantially Equivalent
K853801MENISCAL STITCHING KITSubstantially Equivalent
K853802ATS 500 TOURNIQUETKCYSubstantially Equivalent
K852355SINGLE USE ARTHROSCOPY ELECTRODEGEISubstantially Equivalent
K843801MASON EQUIPMENT ORGANIZER & ASPENFSESubstantially Equivalent
K841558BANANA CUFFKCYSubstantially Equivalent
K831290ELECTRODE, FLEXIBLE SUCTION COAGULATORGEISubstantially Equivalent
K831291ELECTROSURGICAL UNIT-MF 380 #60-1700GEISubstantially Equivalent
K823923MF 360B ELECTROSURGICAL UNITGEISubstantially Equivalent
K813231TOURNIQUETKCYSubstantially Equivalent
K810300FIBER OPTIC ADAPTERS#60-0893HBISubstantially Equivalent
K810299FIBER OPTIC ADAPTERS#60-0891HBISubstantially Equivalent
K810103ADULT ECG ELECTRODE #60-0724DRXSubstantially Equivalent
K810102INFANT ECG ELECTRODE #60-1029DRXSubstantially Equivalent
K810101WATER RESISTANT FOOTSWITCH W/CABLEGEISubstantially Equivalent
K802775FIBER OPTIC ADAPTER #60-0896EQHSubstantially Equivalent
K802774FIBER OPTIC ADAPTER #60-0892EQHSubstantially Equivalent
K802773FIBER OPTIC LIGHT GUIDE #60-0767EQHSubstantially Equivalent
K802772FIBER OPTIC ADAPTER #60-0894EQHSubstantially Equivalent
K802771FIBER OPTIC ADAPTER #60-895EQHSubstantially Equivalent
K802768FIBER OPTIC ADAPTER #60-0897EQHSubstantially Equivalent
K802767FIBER OPTIC LIGHT GUIDE CAT#60-0768EQHSubstantially Equivalent
K802766FIBER OPTIC ADAPTER CAT#60-0898EQHSubstantially Equivalent
K802770FIBER OPTIC HEADLIGHT #60-0766766FCTSubstantially Equivalent
K802769FIBER OPTIC HEADLIGHT #60-0765FCTSubstantially Equivalent
K801176FIBER OPTIC LIGHT SOURCEEQHSubstantially Equivalent
K800597REUSABLE HAND-TROLGEISubstantially Equivalent
K790770SAFETY HOLSTER, SINGLE-USEGEISubstantially Equivalent
K781429HAND-TROL CONNECTOR EXTENDERGEISubstantially Equivalent
K780978SINGLE USE ACTIVE ELECTRODE HANDLEGEISubstantially 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