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FDA 510(k)

BODAI SWIVEL Y

K-Number: K813324 · 1981-12-29

ApplicantSontek Industries, Inc.
Decision Date1981-12-29
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BODAI SWIVEL Y is the device name listed in this FDA 510(k) record. The listed applicant is Sontek Industries, Inc.. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813324. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODAI SWIVEL Y?

BODAI SWIVEL Y is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Sontek Industries, Inc.. The 510(k) number is K813324.

When did BODAI SWIVEL Y receive FDA 510(k) clearance?

BODAI SWIVEL Y received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813324.

Who is the listed applicant for BODAI SWIVEL Y?

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

What is the FDA product code for BODAI SWIVEL Y?

The FDA product code for BODAI SWIVEL Y is BSY.

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Other records listing Sontek Industries, 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.

K833374BITE-BLOCKK833373BODIA BRONCH-SAF DOUBLE SWIVELK833372BODIA TRACH-SAF DOUBLE SWIVELK833361TUBE-TITLEK812720BODAI PATIENT COMMUNICATORK811241BODAI SUCTION -SAFE 4

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino 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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