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)

ORAL ASPIRATOR

K-Number: K871315 · 1987-04-15

ApplicantEndovations
Decision Date1987-04-15
Product CodeDYN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAL ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Endovations. It received FDA 510(k) clearance on 1987-04-15 under 510(k) number K871315. The device is classified under product code DYN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL ASPIRATOR?

ORAL ASPIRATOR is a medical device that received FDA 510(k) clearance on 1987-04-15. The listed applicant is Endovations. The 510(k) number is K871315.

When did ORAL ASPIRATOR receive FDA 510(k) clearance?

ORAL ASPIRATOR received FDA 510(k) clearance on 1987-04-15, under 510(k) number K871315.

Who is the listed applicant for ORAL ASPIRATOR?

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

What is the FDA product code for ORAL ASPIRATOR?

The FDA product code for ORAL ASPIRATOR is DYN.

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 Endovations 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.

K955413ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETERK942110INJECT-SNAREK934315ENDOVATIONS(R) .035 PRE-CUT PAPILLATOMEK9138412 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATHK9138705MM MICROSCISSORSK911155OVAL CUP BIOPSY FORCEP

View all 37 devices →

Related Devices (Code: DYN)

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.

K940769DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTORTerraflexK935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing ABK935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.K924211EJECTORGlenroe TechnologiesK920492HIGH VACHygoplastic, Inc.K921117MINIDAMDelsan Dental Systems

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.

↑