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

Dallas, TX, US

INSIGHTEC, LTD. appears in FDA device records in Dallas, TX. FDA records list 2 510(k) clearances between and , 72 PMA records and 2 registered establishments. 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
2
PMA records
72
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 2 510(k) clearances for Insightec, Ltd. between 2021 and 2023. The busiest year on record is 2021, with 1. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Insightec, Ltd., by decision year
YearClearances
20211
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0PLPSubstantially Equivalent
K212150Exablate Prostate SystemPLPSubstantially Equivalent

Registered establishments

FDA registered establishments for Insightec, Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96150583003105983INSIGHTEC, LTD.5 NAHUM HETH ST., TIRAT CARMEL Haifa 39120 IL2026
30071457363003004504InSightec, Inc.4851 Lbj Fwy Ste 300, Dallas, TX 75244 US2026No device listings on this registration

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