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FDA 510(k)

ORIBRUSH - WITH PROTECTIVE TIP - B001

K-Number: K991595 · 1999-06-29

ApplicantOrifice Medical AB
Decision Date1999-06-29
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ORIBRUSH - WITH PROTECTIVE TIP - B001 is the device name listed in this FDA 510(k) record. The listed applicant is Orifice Medical AB. It received FDA 510(k) clearance on 1999-06-29 under 510(k) number K991595. 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 ORIBRUSH - WITH PROTECTIVE TIP - B001?

ORIBRUSH - WITH PROTECTIVE TIP - B001 is a medical device that received FDA 510(k) clearance on 1999-06-29. The listed applicant is Orifice Medical AB. The 510(k) number is K991595.

When did ORIBRUSH - WITH PROTECTIVE TIP - B001 receive FDA 510(k) clearance?

ORIBRUSH - WITH PROTECTIVE TIP - B001 received FDA 510(k) clearance on 1999-06-29, under 510(k) number K991595.

Who is the listed applicant for ORIBRUSH - WITH PROTECTIVE TIP - B001?

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

What is the FDA product code for ORIBRUSH - WITH PROTECTIVE TIP - B001?

The FDA product code for ORIBRUSH - WITH PROTECTIVE TIP - B001 is HHT.

Related Clinical Trials

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Other records listing Orifice Medical AB 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.

K991593ORIBRUSH - STANDARD - B002

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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