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FDA 510(k)

Q-5000

K-Number: K961971 · 1996-06-28

ApplicantStryker Endoscopy
Decision Date1996-06-28
Product CodeFSS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Q-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 1996-06-28 under 510(k) number K961971. 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 Q-5000?

Q-5000 is a medical device that received FDA 510(k) clearance on 1996-06-28. The listed applicant is Stryker Endoscopy. The 510(k) number is K961971.

When did Q-5000 receive FDA 510(k) clearance?

Q-5000 received FDA 510(k) clearance on 1996-06-28, under 510(k) number K961971.

Who is the listed applicant for Q-5000?

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

What is the FDA product code for Q-5000?

The FDA product code for Q-5000 is FSS.

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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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