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)

GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE

K-Number: K061539 · 2007-09-20

ApplicantClinical Innovations, LLC
Decision Date2007-09-20
Product CodeHFX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Innovations, LLC. It received FDA 510(k) clearance on 2007-09-20 under 510(k) number K061539. 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 GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE?

GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE is a medical device that received FDA 510(k) clearance on 2007-09-20. The listed applicant is Clinical Innovations, LLC. The 510(k) number is K061539.

When did GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE receive FDA 510(k) clearance?

GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE received FDA 510(k) clearance on 2007-09-20, under 510(k) number K061539.

Who is the listed applicant for GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE?

The FDA 510(k) record lists Clinical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE?

The FDA product code for GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE 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 Clinical Innovations, LLC 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.

K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)K250897Koala Intrauterine Pressure Catheter (IPC-5000E)K223900babyLance Safety Heelstick (BLM, BLN, BLP)K153591ebb Complete Tamponade SystemK110605ROM PLUS

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.

↑