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)

ANSPACH EMAX DRILL SYSTEM

K-Number: K011444 · 2001-08-08

ApplicantThe Anspach Effort, Inc.
Decision Date2001-08-08
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ANSPACH EMAX DRILL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 2001-08-08 under 510(k) number K011444. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANSPACH EMAX DRILL SYSTEM?

ANSPACH EMAX DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-08. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K011444.

When did ANSPACH EMAX DRILL SYSTEM receive FDA 510(k) clearance?

ANSPACH EMAX DRILL SYSTEM received FDA 510(k) clearance on 2001-08-08, under 510(k) number K011444.

Who is the listed applicant for ANSPACH EMAX DRILL SYSTEM?

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

What is the FDA product code for ANSPACH EMAX DRILL SYSTEM?

The FDA product code for ANSPACH EMAX DRILL SYSTEM is HBC.

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 The Anspach Effort, 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.

K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)K183545Anspach Helix Dissection ToolsK180063OCM-G1 AttachmentK131053ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEMK113476ANSPACH DISSECTION TOOLSK082637CRANIAL PERFORATOR

View all 59 devices →

Related Devices (Code: HBC)

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.

K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.

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.

↑