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FDA 510(k)

ANSPACH MRI SAFE SURGICAL DRILL SYSTEM

K-Number: K040186 · 2004-04-15

ApplicantThe Anspach Effort, Inc.
Decision Date2004-04-15
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ANSPACH MRI SAFE SURGICAL 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 2004-04-15 under 510(k) number K040186. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANSPACH MRI SAFE SURGICAL DRILL SYSTEM?

ANSPACH MRI SAFE SURGICAL DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-15. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K040186.

When did ANSPACH MRI SAFE SURGICAL DRILL SYSTEM receive FDA 510(k) clearance?

ANSPACH MRI SAFE SURGICAL DRILL SYSTEM received FDA 510(k) clearance on 2004-04-15, under 510(k) number K040186.

Who is the listed applicant for ANSPACH MRI SAFE SURGICAL 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 MRI SAFE SURGICAL DRILL SYSTEM?

The FDA product code for ANSPACH MRI SAFE SURGICAL DRILL SYSTEM is HBB.

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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

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Related Devices (Code: HBB)

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.

K253772Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AGK172907ELAN 4 Air Motor SystemAesculap, Inc.K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesMedtronic Powered Surgical SolutionsK101168LEGEND POWER ADAPTER MODEL: 6475000Medtronic Sofamor DanekK093361SYNTHES AIR PEN DRIVE (APD) SYSTEMSynthes (Usa)K090112MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical Solutions

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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