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FDA 510(k)

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

K-Number: K251852 · 2026-02-13

ApplicantVPIX Medical, Inc.
Decision Date2026-02-13
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) is the device name listed in this FDA 510(k) record. The listed applicant is VPIX Medical, Inc.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251852. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is VPIX Medical, Inc.. The 510(k) number is K251852.

When did cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) receive FDA 510(k) clearance?

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251852.

Who is the listed applicant for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

The FDA 510(k) record lists VPIX Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)?

The FDA product code for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) is OWN.

Other records listing VPIX Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233391cCeLL - In vivo

Related Devices (Code: OWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KGK260108L12 LED Light Source with AIMStryker EndoscopyK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KGK251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)Olympus Medical Systems Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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