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FDA 510(k)

HESLIN DISPOS. TUBING SET

K-Number: K843041 · 1984-11-21

ApplicantInnovative Surgical Products, Inc.
Decision Date1984-11-21
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HESLIN DISPOS. TUBING SET 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 1984-11-21 under 510(k) number K843041. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HESLIN DISPOS. TUBING SET?

HESLIN DISPOS. TUBING SET is a medical device that received FDA 510(k) clearance on 1984-11-21. The listed applicant is Innovative Surgical Products, Inc.. The 510(k) number is K843041.

When did HESLIN DISPOS. TUBING SET receive FDA 510(k) clearance?

HESLIN DISPOS. TUBING SET received FDA 510(k) clearance on 1984-11-21, under 510(k) number K843041.

Who is the listed applicant for HESLIN DISPOS. TUBING SET?

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 HESLIN DISPOS. TUBING SET?

The FDA product code for HESLIN DISPOS. TUBING SET is HQE.

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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.

K840693DISPOSABLE SCLERAL GLOBE PLUGK840695PHACOEMULSIFICATION KITSK840694LENS INSERTION GLIDEK841072IRRIGATION, ASPIRATION TUBING SETSK832235DISPOSABLE VITRECTOMY HANDPIECEK821496DISPOSABLE IRRIGA/ASPIR. SYSTEM

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Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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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