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

CHEPSTOW Monmouthshire, GB

CREO MEDICAL LTD appears in FDA device records in CHEPSTOW Monmouthshire, GB. FDA records list 10 510(k) clearances between and , no 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
10
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 10 510(k) clearances for Creo Medical Ltd between 2017 and 2025. The busiest year on record is 2023, with 3. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Creo Medical Ltd, by decision year
YearClearances
20171
20202
20211
20233
20241
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242774SpydrBlade Flex Instrument (PRD-RG1-001)KNSSubstantially Equivalent
K242983CROMA Electrosurgical Generator (PRD-EMR-050)GEISubstantially Equivalent
K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)KNSSubstantially Equivalent
K230328Speedboat Flush SB1 InstrumentKNSSubstantially Equivalent
K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemNEYSubstantially Equivalent
K221672Creo Electrosurgical System with NP1 InstrumentNEYSubstantially Equivalent
K200298ABI Instrument, Creo Electrosurgical SystemNEYSubstantially Equivalent
K200003NP1 Instrument, Creo Electrosurgical SystemNEYSubstantially Equivalent
K192905Creo Electrosurgical System with HS1 Hemostasis AccessoryKNSUnknown
K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryKNSSubstantially Equivalent

Registered establishments

FDA registered establishments for Creo Medical Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30149254133014925413CREO MEDICAL LTDUnit 2, Beaufort Park, CHEPSTOW Monmouthshire NP16 5UH GB2026
30196452233019645223CREO MEDICAL, INC100 Reserve Road, Danbury, CT 06810 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