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)

SUH VENT TUBE

K-Number: K910618 · 1991-06-28

ApplicantBoston Medical Products, Inc.
Decision Date1991-06-28
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SUH VENT TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Medical Products, Inc.. It received FDA 510(k) clearance on 1991-06-28 under 510(k) number K910618. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUH VENT TUBE?

SUH VENT TUBE is a medical device that received FDA 510(k) clearance on 1991-06-28. The listed applicant is Boston Medical Products, Inc.. The 510(k) number is K910618.

When did SUH VENT TUBE receive FDA 510(k) clearance?

SUH VENT TUBE received FDA 510(k) clearance on 1991-06-28, under 510(k) number K910618.

Who is the listed applicant for SUH VENT TUBE?

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

What is the FDA product code for SUH VENT TUBE?

The FDA product code for SUH VENT TUBE is ETD.

Other records listing Boston Medical Products, 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.

K091135RUTTER SUPRA STOMAL STENTSK972317MONTGOMERY THYROPLASTY IMPLANT SYSTEMK972459RHINOCELL NASAL PACKINGSK972096BIVALVE NASAL SPLINTK972078POST-STOP EPISTAXIS CATHETERK972092NASAL AIRWAY SPLINT

View all 33 devices →

Related Devices (Code: ETD)

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.

K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc.K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))Aventamed DacK232702Solo+ Tympanostomy Tube Device (TTD)Aventamed DacK233658Biowy Tym Tube (TT)Biowy CorporationK232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, 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.

↑