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FDA 510(k)

CURELLE

K-Number: K915491 · 1992-11-04

ApplicantBioteque Corp.
Decision Date1992-11-04
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CURELLE is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corp.. It received FDA 510(k) clearance on 1992-11-04 under 510(k) number K915491. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CURELLE?

CURELLE is a medical device that received FDA 510(k) clearance on 1992-11-04. The listed applicant is Bioteque Corp.. The 510(k) number is K915491.

When did CURELLE receive FDA 510(k) clearance?

CURELLE received FDA 510(k) clearance on 1992-11-04, under 510(k) number K915491.

Who is the listed applicant for CURELLE?

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

What is the FDA product code for CURELLE?

The FDA product code for CURELLE is HHK.

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Other records listing Bioteque Corp. 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.

K150932Sheath IntroducerK102633BIOTEQ ANGIOGRAPHIC CATHETERK033862BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCKK033210BIOTEQ DOUBLE PIGTAIL URETERAL STENT SETK032292BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEXK013634BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK

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Related Devices (Code: HHK)

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.

K251882Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi)K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)Li Medical Corporation , Ltd.K201952CrossGlide ETS PlusCrossbay MedicalK192534CrossBay Endometrial Tissue Sampler (ETS)Crossbay MedicalK102847DISPOSABLE ENDOMETRIAL SUCTION CURETTEJiangsu Suyun Medical Materials Co., Ltd.K092982THE PANPAC SUCTION CURETTEPanpac Medical Corporation

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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