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)

MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.

K-Number: K870149 · 1987-04-06

ApplicantRadionics, Inc.
Decision Date1987-04-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG. is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1987-04-06 under 510(k) number K870149. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.?

MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG. is a medical device that received FDA 510(k) clearance on 1987-04-06. The listed applicant is Radionics, Inc.. The 510(k) number is K870149.

When did MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG. receive FDA 510(k) clearance?

MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG. received FDA 510(k) clearance on 1987-04-06, under 510(k) number K870149.

Who is the listed applicant for MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.?

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

What is the FDA product code for MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.?

The FDA product code for MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG. is GEI.

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 Radionics, 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.

K030697RADIONICS SINGLE USE GROUND PAD (DGP-HP)K002773NEUROMAP WITH NEURO 100K001741RADIONICS RF DISC CATHETER ELECTRODE SYSTEMK992226XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEMK001950OPTICAL TRACKING SYSTEM (OTS)K001700XPLAN 2.1

View all 56 devices →

Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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.

↑