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FDA 510(k)

SONOHYSTEROGRAPHY BIOPSY DEVICE

K-Number: K060908 · 2006-06-29

ApplicantCook Urological, Inc.
Decision Date2006-06-29
Product CodePGK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SONOHYSTEROGRAPHY BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2006-06-29 under 510(k) number K060908. The device is classified under product code PGK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOHYSTEROGRAPHY BIOPSY DEVICE?

SONOHYSTEROGRAPHY BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 2006-06-29. The listed applicant is Cook Urological, Inc.. The 510(k) number is K060908.

When did SONOHYSTEROGRAPHY BIOPSY DEVICE receive FDA 510(k) clearance?

SONOHYSTEROGRAPHY BIOPSY DEVICE received FDA 510(k) clearance on 2006-06-29, under 510(k) number K060908.

Who is the listed applicant for SONOHYSTEROGRAPHY BIOPSY DEVICE?

The FDA 510(k) record lists Cook Urological, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOHYSTEROGRAPHY BIOPSY DEVICE?

The FDA product code for SONOHYSTEROGRAPHY BIOPSY DEVICE is PGK.

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Other records listing Cook Urological, Inc. 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

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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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