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FDA 510(k)

DETECT (TM) CYTOLOGY BRUSH

K-Number: K933415 · 1994-02-25

ApplicantCook Ob/Gyn
Decision Date1994-02-25
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DETECT (TM) CYTOLOGY BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K933415. 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 DETECT (TM) CYTOLOGY BRUSH?

DETECT (TM) CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Cook Ob/Gyn. The 510(k) number is K933415.

When did DETECT (TM) CYTOLOGY BRUSH receive FDA 510(k) clearance?

DETECT (TM) CYTOLOGY BRUSH received FDA 510(k) clearance on 1994-02-25, under 510(k) number K933415.

Who is the listed applicant for DETECT (TM) CYTOLOGY BRUSH?

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

What is the FDA product code for DETECT (TM) CYTOLOGY BRUSH?

The FDA product code for DETECT (TM) CYTOLOGY BRUSH is HHT.

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Other records listing Cook Ob/Gyn 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.

K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500K030441SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KITK023850SYDNEY IVF EMBRYO BIOPSY MEDIUMK013597TAMPONADE UTERINE BALLOON CATHETER SETK002385COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,K002383COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT

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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

View on FDA Database →

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

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