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FDA 510(k)

DISPOSABLE IRRIGA/ASPIR. SYSTEM

K-Number: K821496 · 1982-06-22

ApplicantInnovative Surgical Products, Inc.
Decision Date1982-06-22
Product CodeKDH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE IRRIGA/ASPIR. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Products, Inc.. It received FDA 510(k) clearance on 1982-06-22 under 510(k) number K821496. The device is classified under product code KDH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE IRRIGA/ASPIR. SYSTEM?

DISPOSABLE IRRIGA/ASPIR. SYSTEM is a medical device that received FDA 510(k) clearance on 1982-06-22. The listed applicant is Innovative Surgical Products, Inc.. The 510(k) number is K821496.

When did DISPOSABLE IRRIGA/ASPIR. SYSTEM receive FDA 510(k) clearance?

DISPOSABLE IRRIGA/ASPIR. SYSTEM received FDA 510(k) clearance on 1982-06-22, under 510(k) number K821496.

Who is the listed applicant for DISPOSABLE IRRIGA/ASPIR. SYSTEM?

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

What is the FDA product code for DISPOSABLE IRRIGA/ASPIR. SYSTEM?

The FDA product code for DISPOSABLE IRRIGA/ASPIR. SYSTEM is KDH.

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Other records listing Innovative 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.

K843041HESLIN DISPOS. TUBING SETK840693DISPOSABLE SCLERAL GLOBE PLUGK840695PHACOEMULSIFICATION KITSK840694LENS INSERTION GLIDEK841072IRRIGATION, ASPIRATION TUBING SETSK832235DISPOSABLE VITRECTOMY HANDPIECE

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Related Devices (Code: KDH)

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.

K983624GILTECH PLUS CONNECTING TUBE SETGiltech Plus, Inc.K981286SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETSArmm, Inc.K971259COMBIPORT FLUID LAVAGE DEVICEB.Braun Medical, Inc.K962850TUM-E-VACEthox Corp.K951533EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITBallard Medical ProductsK923497FLUSHING IRRIGATION SETOrion Life Systems, 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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