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)

ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)

K-Number: K884709 · 1989-09-08

ApplicantPrimrose Medical, Inc.
Decision Date1989-09-08
Product CodeODD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) is the device name listed in this FDA 510(k) record. The listed applicant is Primrose Medical, Inc.. It received FDA 510(k) clearance on 1989-09-08 under 510(k) number K884709. The device is classified under product code ODD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)?

ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Primrose Medical, Inc.. The 510(k) number is K884709.

When did ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) receive FDA 510(k) clearance?

ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) received FDA 510(k) clearance on 1989-09-08, under 510(k) number K884709.

Who is the listed applicant for ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)?

The FDA 510(k) record lists Primrose Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)?

The FDA product code for ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) is ODD.

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 Primrose Medical, Inc. 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.

K884713COLONIC BALLOON DIALATORSK884714BILIARY DIALATORK884715ACHELASIA BALLOON DIALATORK884711URETHRAL AND URETERAL BALLOON DILATATORSK884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSK883420LANCET, BLOOD

View all 14 devices →

Related Devices (Code: ODD)

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.

K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614MOlympus Medical Systems Corp.K202583BioShield biopsy valve EUS - LinearSTERIS CorporationK171989Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal CatheterWilson-Cook Medical, Inc.K070420BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138United States Endoscopy Group, Inc.K011149DISPOSABLE BENDING CANNULA PR-233QThe Olympus Optical Co.K010993ALIEN RX MICRO CANNULA, MODEL 4530Boston Scientific 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.

↑