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FDA 510(k)

ORIBRUSH - STANDARD - B002

K-Number: K991593 · 1999-06-29

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

Device Summary

ORIBRUSH - STANDARD - B002 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 K991593. 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 - STANDARD - B002?

ORIBRUSH - STANDARD - B002 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 K991593.

When did ORIBRUSH - STANDARD - B002 receive FDA 510(k) clearance?

ORIBRUSH - STANDARD - B002 received FDA 510(k) clearance on 1999-06-29, under 510(k) number K991593.

Who is the listed applicant for ORIBRUSH - STANDARD - B002?

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 - STANDARD - B002?

The FDA product code for ORIBRUSH - STANDARD - B002 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.

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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.

K991595ORIBRUSH - WITH PROTECTIVE TIP - B001

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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