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FDA 510(k)

TUBE-STAT

K-Number: K843490 · 1984-10-04

ApplicantConcept, Inc.
Decision Date1984-10-04
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TUBE-STAT is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1984-10-04 under 510(k) number K843490. The device is classified under product code BSR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUBE-STAT?

TUBE-STAT is a medical device that received FDA 510(k) clearance on 1984-10-04. The listed applicant is Concept, Inc.. The 510(k) number is K843490.

When did TUBE-STAT receive FDA 510(k) clearance?

TUBE-STAT received FDA 510(k) clearance on 1984-10-04, under 510(k) number K843490.

Who is the listed applicant for TUBE-STAT?

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

What is the FDA product code for TUBE-STAT?

The FDA product code for TUBE-STAT is BSR.

Other records listing Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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Related Devices (Code: BSR)

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.

K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft TipCook IncorporatedK962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDLaerdal Medical Corp.K954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)Laerdal Medical Corp.K943104MOLLOY INTUBATING STYLETTEMolloy Corp.K955238RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLERusch Intl.K953677LIGHTED FLEXGUIDE (MODIFICATION)Scientific Sales Intl., 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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