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FDA 510(k)

OPTHERM FINE TIP

K-Number: K840425 · 1984-05-09

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-05-09
Product CodeHQP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTHERM FINE TIP is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Medical Manufacturers, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K840425. The device is classified under product code HQP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTHERM FINE TIP?

OPTHERM FINE TIP is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K840425.

When did OPTHERM FINE TIP receive FDA 510(k) clearance?

OPTHERM FINE TIP received FDA 510(k) clearance on 1984-05-09, under 510(k) number K840425.

Who is the listed applicant for OPTHERM FINE TIP?

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

What is the FDA product code for OPTHERM FINE TIP?

The FDA product code for OPTHERM FINE TIP is HQP.

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 Suncoast Medical Manufacturers, 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.

K841604ADJUST-A-TEMP HIGH TEMPERATUREK841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841603ADJUST-A-TEMP MICROK841459REPLACE-A-TIP ADJUST. LOW TEMP.-K841591PYRO-TIPK840376SURG-A STAT LOOP TIP

View all 31 devices →

Related Devices (Code: HQP)

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.

K121441CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)Bovie Medical CorporationK083428F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERYFiab SpaK062659KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIESKirwan Surgical Products, Inc.K023506SURGICAL MEDICAL DEVICE CAUTERYModern Medical Equipment Mfg., Ltd.K002547STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTORStarion InstrumentsK994019CAUTERY GRASPER/DISSECTORStarion Instruments

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.

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