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)

SHEPPERD SHELTER TUBE COMPLETE & DRILL

K-Number: K900613 · 1990-10-22

ApplicantDowns Surgical , Ltd.
Decision Date1990-10-22
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHEPPERD SHELTER TUBE COMPLETE & DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K900613. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEPPERD SHELTER TUBE COMPLETE & DRILL?

SHEPPERD SHELTER TUBE COMPLETE & DRILL is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K900613.

When did SHEPPERD SHELTER TUBE COMPLETE & DRILL receive FDA 510(k) clearance?

SHEPPERD SHELTER TUBE COMPLETE & DRILL received FDA 510(k) clearance on 1990-10-22, under 510(k) number K900613.

Who is the listed applicant for SHEPPERD SHELTER TUBE COMPLETE & DRILL?

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

What is the FDA product code for SHEPPERD SHELTER TUBE COMPLETE & DRILL?

The FDA product code for SHEPPERD SHELTER TUBE COMPLETE & DRILL is HRX.

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 Downs Surgical , Ltd. 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.

K903750ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-EK903747ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-UK903749ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-UK903748ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-VK900609SHEPPERD STRAIGHT AND CURVED NEEDLESK900616SHEPPERD CUTTING FORCEPS

View all 60 devices →

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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.

↑