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)

AMSEN DOUBLE-ENDED FORAMINAL PROBE

K-Number: K921642 · 1992-06-03

ApplicantAdvanced Med/Surg, Inc.
Decision Date1992-06-03
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMSEN DOUBLE-ENDED FORAMINAL PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Med/Surg, Inc.. It received FDA 510(k) clearance on 1992-06-03 under 510(k) number K921642. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSEN DOUBLE-ENDED FORAMINAL PROBE?

AMSEN DOUBLE-ENDED FORAMINAL PROBE is a medical device that received FDA 510(k) clearance on 1992-06-03. The listed applicant is Advanced Med/Surg, Inc.. The 510(k) number is K921642.

When did AMSEN DOUBLE-ENDED FORAMINAL PROBE receive FDA 510(k) clearance?

AMSEN DOUBLE-ENDED FORAMINAL PROBE received FDA 510(k) clearance on 1992-06-03, under 510(k) number K921642.

Who is the listed applicant for AMSEN DOUBLE-ENDED FORAMINAL PROBE?

The FDA 510(k) record lists Advanced Med/Surg, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMSEN DOUBLE-ENDED FORAMINAL PROBE?

The FDA product code for AMSEN DOUBLE-ENDED FORAMINAL PROBE is LXH.

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 Advanced Med/Surg, 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.

K942108COHORT BONE BRUSHK931538AMSET(TM) CANNULATED BONE SCREWK921645AMSEN SPINE IMPACTOR INSTRUMENTSK921644AMSEN HOCKEY STICK CHISELK921643AMSEN POSTERIOR DISC EVACUATORK905023AMSET LOCKING PLATE SYSTEM

View all 10 devices →

Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.

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.

↑