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)

SURGICAL TUBE HOLDER

K-Number: K810788 · 1981-04-17

ApplicantThe Urology Group
Decision Date1981-04-17
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL TUBE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is The Urology Group. It received FDA 510(k) clearance on 1981-04-17 under 510(k) number K810788. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL TUBE HOLDER?

SURGICAL TUBE HOLDER is a medical device that received FDA 510(k) clearance on 1981-04-17. The listed applicant is The Urology Group. The 510(k) number is K810788.

When did SURGICAL TUBE HOLDER receive FDA 510(k) clearance?

SURGICAL TUBE HOLDER received FDA 510(k) clearance on 1981-04-17, under 510(k) number K810788.

Who is the listed applicant for SURGICAL TUBE HOLDER?

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

What is the FDA product code for SURGICAL TUBE HOLDER?

The FDA product code for SURGICAL TUBE HOLDER is FZX.

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 The Urology Group 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.

K831703COVERUPSK831489SURGICAL TUBE HOLDERK810739SUCTION WOUND DRAINAGE DEVICEK810787UROLOGIC TUBE HOLDERK801629COVER-ALL MALE INCONTINENCE DEVICE

Related Devices (Code: FZX)

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.

K914715PARALLELING GUIDESImplant Corp. of AmericaK871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.

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.

↑