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)

BIPOLFORCEPS

K-Number: K863413 · 1986-10-02

ApplicantTreace Medical, Inc.
Decision Date1986-10-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPOLFORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1986-10-02 under 510(k) number K863413. 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 BIPOLFORCEPS?

BIPOLFORCEPS is a medical device that received FDA 510(k) clearance on 1986-10-02. The listed applicant is Treace Medical, Inc.. The 510(k) number is K863413.

When did BIPOLFORCEPS receive FDA 510(k) clearance?

BIPOLFORCEPS received FDA 510(k) clearance on 1986-10-02, under 510(k) number K863413.

Who is the listed applicant for BIPOLFORCEPS?

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

What is the FDA product code for BIPOLFORCEPS?

The FDA product code for BIPOLFORCEPS 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 Treace 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

View all 80 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.

↑