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FDA 510(k)

SURGAIRTOME TWO

K-Number: K781979 · 1978-12-20

ApplicantAmerican Sterilizer Co.
Decision Date1978-12-20
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGAIRTOME TWO is the device name listed in this FDA 510(k) record. The listed applicant is American Sterilizer Co.. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781979. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGAIRTOME TWO?

SURGAIRTOME TWO is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is American Sterilizer Co.. The 510(k) number is K781979.

When did SURGAIRTOME TWO receive FDA 510(k) clearance?

SURGAIRTOME TWO received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781979.

Who is the listed applicant for SURGAIRTOME TWO?

The FDA 510(k) record lists American Sterilizer Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGAIRTOME TWO?

The FDA product code for SURGAIRTOME TWO is HSZ.

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Other records listing American Sterilizer Co. 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.

K943288AMSCO SQ240 SURGICAL LIGHTK931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERK922485CHEMDI-VHP CHEMICAL INDICATORK930493QUANTUM 3080 SURGICAL TABLEK905816ORTHOVISION TABLEK896674AMSCO QUANTUM LIGHT

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Related Devices (Code: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, 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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