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FDA 510(k)

INFUSION HANDLE

K-Number: K881518 · 1988-08-22

ApplicantB&B Medical Assoc., Inc.
Decision Date1988-08-22
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INFUSION HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is B&B Medical Assoc., Inc.. It received FDA 510(k) clearance on 1988-08-22 under 510(k) number K881518. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUSION HANDLE?

INFUSION HANDLE is a medical device that received FDA 510(k) clearance on 1988-08-22. The listed applicant is B&B Medical Assoc., Inc.. The 510(k) number is K881518.

When did INFUSION HANDLE receive FDA 510(k) clearance?

INFUSION HANDLE received FDA 510(k) clearance on 1988-08-22, under 510(k) number K881518.

Who is the listed applicant for INFUSION HANDLE?

The FDA 510(k) record lists B&B Medical Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFUSION HANDLE?

The FDA product code for INFUSION HANDLE is KYG.

Related Clinical Trials

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.

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Other records listing B&B Medical Assoc., 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.

K881707INTROCULAR FLUID INJECTORK881519VAC-G (GUILLOTINE VITRECTOR)K881520VAC (OSCILLATING VITRECTOR)K881517B & B I/A HANDPIECE

Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, 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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