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FDA 510(k)

ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE

K-Number: K892846 · 1989-07-14

ApplicantCook Ob/Gyn
Decision Date1989-07-14
Product CodeHIO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE 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 1989-07-14 under 510(k) number K892846. The device is classified under product code HIO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE?

ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Cook Ob/Gyn. The 510(k) number is K892846.

When did ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE receive FDA 510(k) clearance?

ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE received FDA 510(k) clearance on 1989-07-14, under 510(k) number K892846.

Who is the listed applicant for ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE?

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 ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE?

The FDA product code for ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE is HIO.

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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: HIO)

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.

K960203G.E. STERILE AMNIOCENTESIS TRAYGE Medical SystemsK955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAYContour Fabricators of Florida, Inc.K914419AMNIOTEST(TM)Pro-Lab, Inc.K922960VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLECameo, Inc.K921738SONO-VU US(TM), MODIFICATIONE-Z-Em, Inc.K915863MEGA AMNIOCENTESIS KITMega Medical, 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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