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FDA 510(k)

ANSPACH SHIELDED ATTACHMENT

K-Number: K974025 · 1998-07-06

ApplicantThe Anspach Effort, Inc.
Decision Date1998-07-06
Product CodeGFF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANSPACH SHIELDED ATTACHMENT 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 1998-07-06 under 510(k) number K974025. The device is classified under product code GFF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANSPACH SHIELDED ATTACHMENT?

ANSPACH SHIELDED ATTACHMENT is a medical device that received FDA 510(k) clearance on 1998-07-06. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K974025.

When did ANSPACH SHIELDED ATTACHMENT receive FDA 510(k) clearance?

ANSPACH SHIELDED ATTACHMENT received FDA 510(k) clearance on 1998-07-06, under 510(k) number K974025.

Who is the listed applicant for ANSPACH SHIELDED ATTACHMENT?

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 SHIELDED ATTACHMENT?

The FDA product code for ANSPACH SHIELDED ATTACHMENT is GFF.

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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: GFF)

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.

K950449SURGICAL BURTransidyne General Corp.K943758SURGICAL BURKomet MedicalK934583BURRSAmerican Medical Specialties, Inc.K894438MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTSMicro-Aire Surgical Instruments, Inc.K890090DANEK IRRIGATING BURR (DIB) SETDanek Medical, Inc.K883255KOMET SURGICAL BURKomet Medical, Div. of Brasseler USA I, 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.

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