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FDA 510(k)

SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE

K-Number: K935797 · 1994-01-12

ApplicantStebar Instrument Corp.
Decision Date1994-01-12
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE is the device name listed in this FDA 510(k) record. The listed applicant is Stebar Instrument Corp.. It received FDA 510(k) clearance on 1994-01-12 under 510(k) number K935797. 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 SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE?

SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE is a medical device that received FDA 510(k) clearance on 1994-01-12. The listed applicant is Stebar Instrument Corp.. The 510(k) number is K935797.

When did SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE receive FDA 510(k) clearance?

SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE received FDA 510(k) clearance on 1994-01-12, under 510(k) number K935797.

Who is the listed applicant for SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE?

The FDA 510(k) record lists Stebar Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE?

The FDA product code for SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE is BSR.

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.

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Other records listing Stebar Instrument Corp. 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.

K952266SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE

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

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

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