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 50 BIPOLAR COAGULATOR

K-Number: K972350 · 1997-08-21

ApplicantBoston Surgical Products, Inc.
Decision Date1997-08-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 50 BIPOLAR COAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Boston Surgical Products, Inc.. It received FDA 510(k) clearance on 1997-08-21 under 510(k) number K972350. 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 50 BIPOLAR COAGULATOR?

MODEL 50 BIPOLAR COAGULATOR is a medical device that received FDA 510(k) clearance on 1997-08-21. The listed applicant is Boston Surgical Products, Inc.. The 510(k) number is K972350.

When did MODEL 50 BIPOLAR COAGULATOR receive FDA 510(k) clearance?

MODEL 50 BIPOLAR COAGULATOR received FDA 510(k) clearance on 1997-08-21, under 510(k) number K972350.

Who is the listed applicant for MODEL 50 BIPOLAR COAGULATOR?

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

What is the FDA product code for MODEL 50 BIPOLAR COAGULATOR?

The FDA product code for MODEL 50 BIPOLAR COAGULATOR 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 Boston Surgical Products, 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.

K972311MODEL 20 BIPOLAR COAGULATORK944947ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSK950375DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATORK951912DISOPOSABLE & RESUABLE MONPOLAR CORDK951269DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL

View all 17 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.

↑