FDA 510(k)

AN-10S ANDERSEN TUBE WITH STYLET

K-Number: K935688 · 1994-12-30

Decision Date1994-12-30

Product CodeBSS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AN-10S ANDERSEN TUBE WITH STYLET is the device name listed in this FDA 510(k) record. The listed applicant is H.W. Andersen Products, Inc.. It received FDA 510(k) clearance on 1994-12-30 under 510(k) number K935688. The device is classified under product code BSS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AN-10S ANDERSEN TUBE WITH STYLET?

AN-10S ANDERSEN TUBE WITH STYLET is a medical device that received FDA 510(k) clearance on 1994-12-30. The listed applicant is H.W. Andersen Products, Inc.. The 510(k) number is K935688.

When did AN-10S ANDERSEN TUBE WITH STYLET receive FDA 510(k) clearance?

AN-10S ANDERSEN TUBE WITH STYLET received FDA 510(k) clearance on 1994-12-30, under 510(k) number K935688.

Who is the listed applicant for AN-10S ANDERSEN TUBE WITH STYLET?

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

What is the FDA product code for AN-10S ANDERSEN TUBE WITH STYLET?

The FDA product code for AN-10S ANDERSEN TUBE WITH STYLET is BSS.

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Other records listing H.W. Andersen Products, Inc. as applicant

K872458AN3200 DOUBILET DRAIN K872460AN3000 MAHONEY DRAIN K872459AN3100 MULHOLLAND DRAIN K872457AN3500 WORTH DRAIN

Related Devices (Code: BSS)

K051480ENTERAL FEEDING TUBEBiosearch Medical Products, Inc.K984629MOSS TUBES, INC. NASAL TUBE - MARK IVMoss Tubes, Inc.K961711ASPISAFE GASTRIC TUBEB.Braun Medical, Inc.K933596GASTRIC, CATHETER, IRRIGATION & ASPIRATIONPolamedco, Inc.K930510RADIUS ENTERAL FEEDING TUBERadius Intl., Inc.K934348TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FRTri-Med Specialties, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.