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FDA 510(k)

BERKELEY V-10 VACUUM CURETTAGE SYSTEM

K-Number: K030935 · 2003-06-23

ApplicantAcmi Corporation
Decision Date2003-06-23
Product CodeHHI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BERKELEY V-10 VACUUM CURETTAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2003-06-23 under 510(k) number K030935. The device is classified under product code HHI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERKELEY V-10 VACUUM CURETTAGE SYSTEM?

BERKELEY V-10 VACUUM CURETTAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-23. The listed applicant is Acmi Corporation. The 510(k) number is K030935.

When did BERKELEY V-10 VACUUM CURETTAGE SYSTEM receive FDA 510(k) clearance?

BERKELEY V-10 VACUUM CURETTAGE SYSTEM received FDA 510(k) clearance on 2003-06-23, under 510(k) number K030935.

Who is the listed applicant for BERKELEY V-10 VACUUM CURETTAGE SYSTEM?

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

What is the FDA product code for BERKELEY V-10 VACUUM CURETTAGE SYSTEM?

The FDA product code for BERKELEY V-10 VACUUM CURETTAGE SYSTEM is HHI.

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Other records listing Acmi Corporation 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.

K061975PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PKK060752ACMI DUR-HL LASER SYSTEMSK060269ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEMK051593UROPASS URETERAL ACCESS SHEATH, MODEL 61224K052044ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6ALK043581DUAL LUMEN CATHETER

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Related Devices (Code: HHI)

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.

K171440Berkeley VC-10 Vacuum Curettage SystemGyrus AcmiK983181CYTOPREPCytoprep Inc. Est.K931205MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTERBaxter Healthcare CorpK904160CYTOSMEAR BRUSHBrooke Intl.K900641CANNULA, SUCTION UTERINEWilliams Specialty Products, Inc.K900642SWIVEL ADAPTERWilliams Specialty Products, 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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