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)

MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION

K-Number: K934320 · 1994-02-16

ApplicantMentor O & O, Inc.
Decision Date1994-02-16
Product CodeHQR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION is the device name listed in this FDA 510(k) record. The listed applicant is Mentor O & O, Inc.. It received FDA 510(k) clearance on 1994-02-16 under 510(k) number K934320. The device is classified under product code HQR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION?

MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION is a medical device that received FDA 510(k) clearance on 1994-02-16. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K934320.

When did MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION receive FDA 510(k) clearance?

MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION received FDA 510(k) clearance on 1994-02-16, under 510(k) number K934320.

Who is the listed applicant for MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION?

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

What is the FDA product code for MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION?

The FDA product code for MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION is HQR.

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 Mentor O & O, 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.

K955245MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEMK912904MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEMK915340MENTOR HORIZON LOW VISION MAGNIFIERK910637MENTOR(R) SUR-E-TROL(R)K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305K903878MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT

View all 18 devices →

Related Devices (Code: HQR)

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.

K050308THERMAL CAUTERY PROBEStarion InstrumentsK990064DI-RHEX OPHTHALMIC DIATHERMY SYSTEMOphthalmic Technologies, Inc.K980522REFRACTEC MCS-100Refractec, Inc.K972749PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)C.M. Chance , Ltd.K952151STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)StorzK955158SURGITRONEllman Intl., Inc.

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.

↑