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FDA 510(k)

CONMED LINVATEC SMART GUARD IRRIGATOR

K-Number: K070233 · 2007-04-02

ApplicantConmed Linvatec
Decision Date2007-04-02
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONMED LINVATEC SMART GUARD IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Linvatec. It received FDA 510(k) clearance on 2007-04-02 under 510(k) number K070233. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONMED LINVATEC SMART GUARD IRRIGATOR?

CONMED LINVATEC SMART GUARD IRRIGATOR is a medical device that received FDA 510(k) clearance on 2007-04-02. The listed applicant is Conmed Linvatec. The 510(k) number is K070233.

When did CONMED LINVATEC SMART GUARD IRRIGATOR receive FDA 510(k) clearance?

CONMED LINVATEC SMART GUARD IRRIGATOR received FDA 510(k) clearance on 2007-04-02, under 510(k) number K070233.

Who is the listed applicant for CONMED LINVATEC SMART GUARD IRRIGATOR?

The FDA 510(k) record lists Conmed Linvatec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONMED LINVATEC SMART GUARD IRRIGATOR?

The FDA product code for CONMED LINVATEC SMART GUARD IRRIGATOR is HRX.

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Other records listing Conmed Linvatec 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.

K111779Y-KNOT ALL-SUTURE ANCHOR MODEL HF13K102410MATRYX INTERFERENCE SCREW (5.0-6.5MM)K102339CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICEK101100CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503K092898CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURESK090560CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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