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FDA 510(k)

DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE

K-Number: K945171 · 1995-02-08

ApplicantBoston Surgical Products, Inc.
Decision Date1995-02-08
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Surgical Products, Inc.. It received FDA 510(k) clearance on 1995-02-08 under 510(k) number K945171. 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 DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE?

DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE is a medical device that received FDA 510(k) clearance on 1995-02-08. The listed applicant is Boston Surgical Products, Inc.. The 510(k) number is K945171.

When did DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE receive FDA 510(k) clearance?

DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE received FDA 510(k) clearance on 1995-02-08, under 510(k) number K945171.

Who is the listed applicant for DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE?

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

What is the FDA product code for DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE?

The FDA product code for DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE is KYG.

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Other records listing Boston Surgical Products, 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.

K972311MODEL 20 BIPOLAR COAGULATORK972350MODEL 50 BIPOLAR COAGULATORK944947ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSK950375DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATORK951912DISOPOSABLE & RESUABLE MONPOLAR CORD

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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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