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)

OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS

K-Number: K910707 · 1991-04-10

ApplicantJedmed Instrument Co.
Decision Date1991-04-10
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS is the device name listed in this FDA 510(k) record. The listed applicant is Jedmed Instrument Co.. It received FDA 510(k) clearance on 1991-04-10 under 510(k) number K910707. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS?

OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS is a medical device that received FDA 510(k) clearance on 1991-04-10. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K910707.

When did OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS receive FDA 510(k) clearance?

OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS received FDA 510(k) clearance on 1991-04-10, under 510(k) number K910707.

Who is the listed applicant for OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS?

The FDA 510(k) record lists Jedmed Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS?

The FDA product code for OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS is HOZ.

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 Jedmed Instrument Co. 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.

K021750LID CHAIN EYELID WEIGHTSK954184JED-LIGHT FIBEROPTIC LIGHT SOURCEK944032VIDEO SCOPE SYSTEM (LARYNGOSCOPE)K953457JEDMED SPECTRUM ENT CABINETK950925JEDMED LARYNGEAL SCOPEK950785HORTMANN AIRMATIC AIR CALORIC STIMULATOR

View all 91 devices →

Related Devices (Code: HOZ)

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.

K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000Alphamed, Inc.K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, 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.

↑