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FDA 510(k)

SurgiCount+ System

K-Number: K232250 · 2024-01-11

ApplicantStryker Instruments
Decision Date2024-01-11
Product CodePBZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SurgiCount+ System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K232250. The device is classified under product code PBZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiCount+ System?

SurgiCount+ System is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Stryker Instruments. The 510(k) number is K232250.

When did SurgiCount+ System receive FDA 510(k) clearance?

SurgiCount+ System received FDA 510(k) clearance on 2024-01-11, under 510(k) number K232250.

Who is the listed applicant for SurgiCount+ System?

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

What is the FDA product code for SurgiCount+ System?

The FDA product code for SurgiCount+ System is PBZ.

Related Clinical Trials

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Other records listing Stryker Instruments as applicant

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K261544Hydro Irrigation SystemK253679Hydro Irrigation SystemK252282SurgiCount+ SystemK251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip PointerK250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)

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Related Devices (Code: PBZ)

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.

K252282SurgiCount+ SystemStryker InstrumentsK163507Triton Sponge SystemGauss Surgical, Inc.,K160338Triton SystemGauss Surgical, 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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