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)

AUTO SUTURE PITUITARY SPINAL RONGEUR

K-Number: K943115 · 1994-07-25

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1994-07-25
Product CodeHAO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE PITUITARY SPINAL RONGEUR is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1994-07-25 under 510(k) number K943115. The device is classified under product code HAO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE PITUITARY SPINAL RONGEUR?

AUTO SUTURE PITUITARY SPINAL RONGEUR is a medical device that received FDA 510(k) clearance on 1994-07-25. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K943115.

When did AUTO SUTURE PITUITARY SPINAL RONGEUR receive FDA 510(k) clearance?

AUTO SUTURE PITUITARY SPINAL RONGEUR received FDA 510(k) clearance on 1994-07-25, under 510(k) number K943115.

Who is the listed applicant for AUTO SUTURE PITUITARY SPINAL RONGEUR?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO SUTURE PITUITARY SPINAL RONGEUR?

The FDA product code for AUTO SUTURE PITUITARY SPINAL RONGEUR is HAO.

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 United States Surgical, A Division of Tyco Healthc 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.

K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERK071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORK061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIERK062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSK062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEK061095AUTO SUTUR ENDO GIA STAPLERS

View all 218 devices →

Related Devices (Code: HAO)

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.

K220920Matreneu Percutaneous Balloon Compression KitShenzhen Shineyard Medical Device Co. , Ltd.K940973MULLAN GANGLION MICROCOMPRESSION SETCook, Inc.K951492RIB RESECTORUnited States Surgical, A Division of Tyco HealthcK942971AUTO SUTURE SPINAL DISSECTORUnited States Surgical, A Division of Tyco HealthcK942967AUTO SUTURE SPINAL CURETTEUnited States Surgical, A Division of Tyco HealthcK942969AUTO SUTURE SPINAL NERVE HOOKUnited States Surgical, A Division of Tyco Healthc

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.

↑