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FDA 510(k)

PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER

K-Number: K952414 · 1995-06-23

ApplicantAcacia Laboratories, Inc.
Decision Date1995-06-23
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Acacia Laboratories, Inc.. It received FDA 510(k) clearance on 1995-06-23 under 510(k) number K952414. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER?

PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1995-06-23. The listed applicant is Acacia Laboratories, Inc.. The 510(k) number is K952414.

When did PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER receive FDA 510(k) clearance?

PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER received FDA 510(k) clearance on 1995-06-23, under 510(k) number K952414.

Who is the listed applicant for PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER?

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

What is the FDA product code for PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER?

The FDA product code for PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER is KNY.

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Other records listing Acacia Laboratories, 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.

K952419STERIGAUZE GEL DRESSINGK952420STERIGAUZE WET DRESSINGK951861STERICARE WOUND CARE GELK951914HYDRACARE ABSORBENT WOUND DRESSINGK950344HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETERK913408STERILE PLASTIC DRAPE

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Related Devices (Code: KNY)

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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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