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

Malvern, PA, US

ACCUTOME, INC. appears in FDA device records in Malvern, PA. 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 Accutome, Inc. between 1981 and 2015. The busiest year on record is 1981, with 1. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Accutome, Inc., by decision year
YearClearances
19811
19821
20031
20051
20111
20131
20141
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K1525734SightIYOSubstantially Equivalent
K132549ACCUTIP COVERHKYSubstantially Equivalent
K123349A-SCAN PLUS CONNECTIYOSubstantially Equivalent
K103471UBM PLUSIYNSubstantially Equivalent
K050552PACHPEN PACHYMETER, MODEL 24-5100IYOSubstantially Equivalent
K032956ACCUSONIC A-SCAN MODEL, 24-4000IYOSubstantially Equivalent
K820050KREMER BLADE GAUGEHOESubstantially Equivalent
K810660KREMER CORNEOMETER ULTRASONIC PACHOMETERIYOSubstantially Equivalent

Registered establishments

FDA registered establishments for Accutome, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
25218772521877ACCUTOME, INC.3222 Phoenixville Pike, Malvern, PA 19355 US2026and 38 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