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FDA 510(k)

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)

K-Number: K212511 · 2021-11-04

ApplicantStryker
Decision Date2021-11-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2021-11-04 under approval number K212511. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) is a medical device that received FDA 510(k) clearance on 2021-11-04. It is manufactured by Stryker. The 510(k) number is K212511.

When was 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) approved by the FDA?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) received FDA 510(k) clearance on 2021-11-04, under approval number K212511.

What company makes 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) is manufactured by Stryker.

What is the FDA product code for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)?

The FDA product code for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) is GCJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025)

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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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