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FDA 510(k)

PAP BRUSH

K-Number: K963801 · 1997-04-09

ApplicantYoung OU Brush Co.
Decision Date1997-04-09
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PAP BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Young OU Brush Co.. It received FDA 510(k) clearance on 1997-04-09 under 510(k) number K963801. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAP BRUSH?

PAP BRUSH is a medical device that received FDA 510(k) clearance on 1997-04-09. The listed applicant is Young OU Brush Co.. The 510(k) number is K963801.

When did PAP BRUSH receive FDA 510(k) clearance?

PAP BRUSH received FDA 510(k) clearance on 1997-04-09, under 510(k) number K963801.

Who is the listed applicant for PAP BRUSH?

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

What is the FDA product code for PAP BRUSH?

The FDA product code for PAP BRUSH is HHT.

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

Related Devices (Code: HHT)

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.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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