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FDA 510(k)

GEMINI SURGICAL LIGHT

K-Number: K880198 · 1988-02-10

ApplicantAmerican Sterilizer Co.
Decision Date1988-02-10
Product CodeFSS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GEMINI SURGICAL LIGHT 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 1988-02-10 under 510(k) number K880198. The device is classified under product code FSS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMINI SURGICAL LIGHT?

GEMINI SURGICAL LIGHT is a medical device that received FDA 510(k) clearance on 1988-02-10. The listed applicant is American Sterilizer Co.. The 510(k) number is K880198.

When did GEMINI SURGICAL LIGHT receive FDA 510(k) clearance?

GEMINI SURGICAL LIGHT received FDA 510(k) clearance on 1988-02-10, under 510(k) number K880198.

Who is the listed applicant for GEMINI SURGICAL LIGHT?

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 GEMINI SURGICAL LIGHT?

The FDA product code for GEMINI SURGICAL LIGHT is FSS.

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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: FSS)

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.

K091246ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)Trumpf Medizin Systeme GmbH + Co. KGK003489NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8Medical Illumination International, Inc.K984124AESCULAP XENON LIGHT SOURCEAesculap, Inc.K981962CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCECuda Products Co.K981821VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORAngiolaz, Inc.K981469CERMAX300 LIGHTSOURCECuda Products Co.

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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