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FDA 510(k)

INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE

K-Number: K945288 · 1994-12-02

ApplicantHelix Medical, Inc.
Decision Date1994-12-02
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Helix Medical, Inc.. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K945288. The device is classified under product code EWL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE?

INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Helix Medical, Inc.. The 510(k) number is K945288.

When did INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE receive FDA 510(k) clearance?

INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE received FDA 510(k) clearance on 1994-12-02, under 510(k) number K945288.

Who is the listed applicant for INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE?

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

What is the FDA product code for INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE?

The FDA product code for INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE is EWL.

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Other records listing Helix Medical, 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.

K023259INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200K991587BLOM-SINGER INDWELLING 2000 VOICE PROSTHESISK945287INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICEK932120BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESK932163BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPETK930105BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.

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Related Devices (Code: EWL)

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.

K240763FirstFit Surgical KitFreudenberg Medical, LLCK131947PROVOX VEGA PUNCTURE SETAtos Medical ABK092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)Atos Medical ABK093258BLOM-SINGER INDWELLING TEP OCCLUDERHelix Medical, LLCK090455PROVOX VEGA, MODEL 8130-8135Atos Medical ABK082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESHelix Medical, LLC

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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