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

Gilroy, CA, US

Chalgren Enterprises, Inc. appears in FDA device records in Gilroy, CA. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 21 510(k) clearances for Chalgren Enterprises, Inc. between 1989 and 1999. The busiest year on record is 1995, with 6. The most recent is 1999, with 1.

Clearances by year, as a table
510(k) clearance decisions for Chalgren Enterprises, Inc., by decision year
YearClearances
19891
19924
19932
19942
19956
19965
19991
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K982950FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550IKTSubstantially Equivalent
K960591RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPIKTSubstantially Equivalent
K955335DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODEIKTSubstantially Equivalent
K953361EMG DISC RECORDING ELECTRODEGXYSubstantially Equivalent
K953356EMG RECORDING RING ELECTRODEGXYSubstantially Equivalent
K953354EMG DISC RECORDING ELECTRODEGXYSubstantially Equivalent
K952908EMG DISC RECORDING ELECTRODE WITH PINGXYSubstantially Equivalent
K952690EMG DISC RECORDING ELECTRODE WITH PINGXYSubstantially Equivalent
K953887RE-USABLE CONCENTRIC NEEDLEIKTSubstantially Equivalent
K953886RE-USABLE MONOPOLAR NEEDLEIKTSubstantially Equivalent
K95322032MM NICKEL PLATED DISC ELECTRODEGXYSubstantially Equivalent
K95321922MM STAINLESS STEEL DISC ELECTRODE, WITH PINGXYSubstantially Equivalent
K924277DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDINGHLTSubstantially Equivalent
K931029DISPOSABLE CONCENTRIC NEEDLE ELECTRODEIKTSubstantially Equivalent
K924521DISPOSABLE CONCENTRIC NEEDLE ELECTRODEIKTSubstantially Equivalent
K925706REUSABLE FINGER CLIP RECORDING ELECTRODEGXYSubstantially Equivalent
K923665REUSABLE DUAL DISC BAR RECORDING ELECTRODESJXESubstantially Equivalent
K921504REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELSJXESubstantially Equivalent
K912283DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODEIKTSubstantially Equivalent
K912282DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELSIKTSubstantially Equivalent
K896370DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)GXZSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2446-2010Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.Terminated

Verification record

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