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

Pleasanton, CA, US

CALYXO, INC. appears in FDA device records in Pleasanton, CA. FDA records list 3 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 3 510(k) clearances for Calyxo, Inc. between 2024 and 2026. The busiest year on record is 2026, with 2. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Calyxo, Inc., by decision year
YearClearances
20241
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260965CVAC Aspiration SystemFEDSubstantially Equivalent
K260013CVAC Image ProcessorFGBSubstantially Equivalent
K233472CVAC Aspiration System + CVAC Image ProcessorFEDSubstantially Equivalent

Registered establishments

FDA registered establishments for Calyxo, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30329593933032959393CALYXO, INC.4430 Rosewood Dr., Pleasanton, CA 94588 US2026
30146830693014683069Calyxo, Inc.4473 Willow Road, Pleasanton, CA 94588 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1396-2025CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.Class IOpen, Classified

Verification record

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