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)

P.A. MEDICAL VAGINAL IRRIGATION SET #1130

K-Number: K854595 · 1986-01-13

ApplicantPa Medical Corp.
Decision Date1986-01-13
Product CodeHED
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

P.A. MEDICAL VAGINAL IRRIGATION SET #1130 is the device name listed in this FDA 510(k) record. The listed applicant is Pa Medical Corp.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K854595. The device is classified under product code HED. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.A. MEDICAL VAGINAL IRRIGATION SET #1130?

P.A. MEDICAL VAGINAL IRRIGATION SET #1130 is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Pa Medical Corp.. The 510(k) number is K854595.

When did P.A. MEDICAL VAGINAL IRRIGATION SET #1130 receive FDA 510(k) clearance?

P.A. MEDICAL VAGINAL IRRIGATION SET #1130 received FDA 510(k) clearance on 1986-01-13, under 510(k) number K854595.

Who is the listed applicant for P.A. MEDICAL VAGINAL IRRIGATION SET #1130?

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

What is the FDA product code for P.A. MEDICAL VAGINAL IRRIGATION SET #1130?

The FDA product code for P.A. MEDICAL VAGINAL IRRIGATION SET #1130 is HED.

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 Pa Medical Corp. 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.

K910903INFLATE-A-CUFF #7014K871449ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAGK860084PRESSURE INFUSOR #1900K853309P.A. ENTERAL FEEDING BAG 1100

Related Devices (Code: HED)

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.

K080200WATER WORKS DOUCHING DEVICEAbbott Research Group, Inc.K030056WORRY-REMOVER IRRIGATORCorisen Group, Ltd.K000736LA JOIEGoomi Ehwa, Inc.K902830PERI-BOTTLEOrion Life Systems, Inc.K881216GENT-L-KARE VAGINAL IRRIGATION SETGeneva Laboratories, Inc.K841710MAC LEE VAGINAL IRRIGATORMac Lee Medical Products

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.

↑