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)

BLOM-SINGER SHOWER GUARD

K-Number: K904729 · 1991-02-28

ApplicantHelix Medical, Inc.
Decision Date1991-02-28
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BLOM-SINGER SHOWER GUARD 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 1991-02-28 under 510(k) number K904729. 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 BLOM-SINGER SHOWER GUARD?

BLOM-SINGER SHOWER GUARD is a medical device that received FDA 510(k) clearance on 1991-02-28. The listed applicant is Helix Medical, Inc.. The 510(k) number is K904729.

When did BLOM-SINGER SHOWER GUARD receive FDA 510(k) clearance?

BLOM-SINGER SHOWER GUARD received FDA 510(k) clearance on 1991-02-28, under 510(k) number K904729.

Who is the listed applicant for BLOM-SINGER SHOWER GUARD?

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 BLOM-SINGER SHOWER GUARD?

The FDA product code for BLOM-SINGER SHOWER GUARD is EWL.

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 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 DEVICEK945288INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICEK932120BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESK932163BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET

View all 14 devices →

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.

↑