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FDA 510(k)

CANCEL

K-Number: K812582 · 1981-09-23

ApplicantBio Systems, Inc.
Decision Date1981-09-23
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CANCEL is the device name listed in this FDA 510(k) record. The listed applicant is Bio Systems, Inc.. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812582. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANCEL?

CANCEL is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Bio Systems, Inc.. The 510(k) number is K812582.

When did CANCEL receive FDA 510(k) clearance?

CANCEL received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812582.

Who is the listed applicant for CANCEL?

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

What is the FDA product code for CANCEL?

The FDA product code for CANCEL is EXB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bio Systems, 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.

K851073CUPRIDENT

Related Devices (Code: EXB)

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.

K252140Heylo™ SystemColoplast Corp.K181643SmartBag (SmartPouch)11 Health Technologies LimitedK922730LAKE OSTOMY CARE SETLake Medical Products, Inc.K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/SK880306EMERGENCY-CLEAN UP(TM) ECPCdc Products 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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