Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)

K-Number: K083161 · 2009-03-27

ApplicantConmed Linvatec
Decision Date2009-03-27
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Linvatec. It received FDA 510(k) clearance on 2009-03-27 under 510(k) number K083161. 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 ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)?

ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) is a medical device that received FDA 510(k) clearance on 2009-03-27. The listed applicant is Conmed Linvatec. The 510(k) number is K083161.

When did ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) receive FDA 510(k) clearance?

ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) received FDA 510(k) clearance on 2009-03-27, under 510(k) number K083161.

Who is the listed applicant for ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)?

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 ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)?

The FDA product code for ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) is HRX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 21 devices →

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.

↑