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 MODIFIED ENDO STREAM SUC./IRRI. DEVICE

K-Number: K905426 · 1991-02-11

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1991-02-11
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE 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 1991-02-11 under 510(k) number K905426. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE?

AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K905426.

When did AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE receive FDA 510(k) clearance?

AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905426.

Who is the listed applicant for AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE?

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 MODIFIED ENDO STREAM SUC./IRRI. DEVICE?

The FDA product code for AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE is HET.

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: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

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.

↑