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

Singapore South West, SG

Biobot Surgical Pte. Ltd. appears in FDA device records in Singapore South West, SG. FDA records list 7 510(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
7
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Biobot Surgical Pte. Ltd. between 2011 and 2023. The busiest year on record is 2021, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Biobot Surgical Pte. Ltd., by decision year
YearClearances
20111
20131
20161
20171
20212
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232320iSR`obot Mona Lisa 2.0IYOSubstantially Equivalent
K213411iSR’obot Mona Lisa 2.0IYOSubstantially Equivalent
K203659iSR'obot Mona Lisa 1.0IYOSubstantially Equivalent
K163502iSR'obot Biopsy KitITXSubstantially Equivalent
K161109iSR'obot MRI-US FusionLLZSubstantially Equivalent
K130944ISR'OBOT MONA LISAIYOSubstantially Equivalent
K111347ISROBOT MONA LISAIYOSubstantially Equivalent

Registered establishments

FDA registered establishments for Biobot Surgical Pte. Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30085483233008548323Biobot Surgical Pte. Ltd.79 Ayer Rajah Crescent, #04-05, Singapore South West 139955 SG2026

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