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FDA 510(k)

ProCell Surgical Sponge-Blood Recovery Unit

K-Number: K193361 · 2020-06-01

ApplicantProcell Surgical, Inc.
Decision Date2020-06-01
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ProCell Surgical Sponge-Blood Recovery Unit is a medical device manufactured by Procell Surgical, Inc.. It received FDA 510(k) clearance on 2020-06-01 under approval number K193361. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProCell Surgical Sponge-Blood Recovery Unit?

ProCell Surgical Sponge-Blood Recovery Unit is a medical device that received FDA 510(k) clearance on 2020-06-01. It is manufactured by Procell Surgical, Inc.. The 510(k) number is K193361.

When was ProCell Surgical Sponge-Blood Recovery Unit approved by the FDA?

ProCell Surgical Sponge-Blood Recovery Unit received FDA 510(k) clearance on 2020-06-01, under approval number K193361.

What company makes ProCell Surgical Sponge-Blood Recovery Unit?

ProCell Surgical Sponge-Blood Recovery Unit is manufactured by Procell Surgical, Inc..

What is the FDA product code for ProCell Surgical Sponge-Blood Recovery Unit?

The FDA product code for ProCell Surgical Sponge-Blood Recovery Unit is CAC.

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Related PubMed Literature

PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (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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