Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ONE/CIRC (CIRCUMCISION CLAMP)

K-Number: K900370 · 1990-04-16

ApplicantBionix Development Corp.
Decision Date1990-04-16
Product CodeHFX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ONE/CIRC (CIRCUMCISION CLAMP) is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K900370. The device is classified under product code HFX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE/CIRC (CIRCUMCISION CLAMP)?

ONE/CIRC (CIRCUMCISION CLAMP) is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Bionix Development Corp.. The 510(k) number is K900370.

When did ONE/CIRC (CIRCUMCISION CLAMP) receive FDA 510(k) clearance?

ONE/CIRC (CIRCUMCISION CLAMP) received FDA 510(k) clearance on 1990-04-16, under 510(k) number K900370.

Who is the listed applicant for ONE/CIRC (CIRCUMCISION CLAMP)?

The FDA 510(k) record lists Bionix Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE/CIRC (CIRCUMCISION CLAMP)?

The FDA product code for ONE/CIRC (CIRCUMCISION CLAMP) is HFX.

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 Bionix Development Corp. 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.

K153270TruGuard Custom Tongue and Jaw PositionerK123411LITTLE ANGELS SWADDLING BLANKETK120335EMBRACE THERMOPLASTICK100691OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500K100264T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060K050701THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010

View all 12 devices →

Related Devices (Code: HFX)

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.

K251687Konig Bell Circumcision ClampMedline Industries, LPK221356Wee BellWee MedicalK212911Konig Mogen ClampMedline Industries, Inc.K131373SHANGRINGWuhu Snnda Medical Treatment Appliance TechnologyK121789SHANGRINGWuhu Snna Medical Treatment Appliance Technology CK103695PREPEX SYSTEMCirc Medtech

Official Source

View on FDA Database →

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

↑