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FDA 510(k)

BLOM-SINGER SEPTAL PERFORATION PROSTHESIS

K-Number: K131745 · 2013-09-17

ApplicantHelix Medical, LLC
Decision Date2013-09-17
Product CodeLFB
DecisionSubstantially Equivalent

Device Summary

BLOM-SINGER SEPTAL PERFORATION PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Helix Medical, LLC. It received FDA 510(k) clearance on 2013-09-17 under 510(k) number K131745. The device is classified under product code LFB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOM-SINGER SEPTAL PERFORATION PROSTHESIS?

BLOM-SINGER SEPTAL PERFORATION PROSTHESIS is a medical device that received FDA 510(k) clearance on 2013-09-17. The listed applicant is Helix Medical, LLC. The 510(k) number is K131745.

When did BLOM-SINGER SEPTAL PERFORATION PROSTHESIS receive FDA 510(k) clearance?

BLOM-SINGER SEPTAL PERFORATION PROSTHESIS received FDA 510(k) clearance on 2013-09-17, under 510(k) number K131745.

Who is the listed applicant for BLOM-SINGER SEPTAL PERFORATION PROSTHESIS?

The FDA 510(k) record lists Helix Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOM-SINGER SEPTAL PERFORATION PROSTHESIS?

The FDA product code for BLOM-SINGER SEPTAL PERFORATION PROSTHESIS is LFB.

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.

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Other records listing Helix Medical, LLC 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.

K130736BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESISK093258BLOM-SINGER INDWELLING TEP OCCLUDERK082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES

Related Devices (Code: LFB)

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.

K013696SILMED NASAL SEPTAL BUTTONSilmed, Inc.K982667MICROMEDICS NASAL SEPTAL BUTTONMicromedics, Inc.K972060NASAL SEPTAL BUTTONBoston Medical Products, Inc.K920994HOOD NASAL SEPTAL BUTTONHood LaboratoriesK901366INVOTEC SEPTAL BUTTONInvotec International, Inc.K871072OMEGA NASAL SEPTAL BUTTONOmega Silicone, Inc.

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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