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)

GYNASPYR VACUUM CURETTAGE UNIT

K-Number: K850312 · 1985-02-28

ApplicantRoseburg SA
Decision Date1985-02-28
Product CodeHHI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNASPYR VACUUM CURETTAGE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1985-02-28 under 510(k) number K850312. The device is classified under product code HHI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNASPYR VACUUM CURETTAGE UNIT?

GYNASPYR VACUUM CURETTAGE UNIT is a medical device that received FDA 510(k) clearance on 1985-02-28. The listed applicant is Roseburg SA. The 510(k) number is K850312.

When did GYNASPYR VACUUM CURETTAGE UNIT receive FDA 510(k) clearance?

GYNASPYR VACUUM CURETTAGE UNIT received FDA 510(k) clearance on 1985-02-28, under 510(k) number K850312.

Who is the listed applicant for GYNASPYR VACUUM CURETTAGE UNIT?

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

What is the FDA product code for GYNASPYR VACUUM CURETTAGE UNIT?

The FDA product code for GYNASPYR VACUUM CURETTAGE UNIT is HHI.

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 Roseburg SA 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.

K931155STAPLE, FIXATION BONE; SCREW FIXATION BONEK890081CALIUS-ISABEL CANOVAS SUNGLASSESK885275ASSENAT-BLESCHET SUNGLASSESK882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK874317POIRIER KID-ROLLER MANUAL WHEELCHAIR

View all 24 devices →

Related Devices (Code: HHI)

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.

K171440Berkeley VC-10 Vacuum Curettage SystemGyrus AcmiK030935BERKELEY V-10 VACUUM CURETTAGE SYSTEMAcmi CorporationK983181CYTOPREPCytoprep Inc. Est.K931205MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTERBaxter Healthcare CorpK904160CYTOSMEAR BRUSHBrooke Intl.K900641CANNULA, SUCTION UTERINEWilliams Specialty Products, Inc.

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.

↑