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FDA 510(k)

STATSEAL DISC

K-Number: K130324 · 2013-07-09

ApplicantBiolife, LLC
Decision Date2013-07-09
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

STATSEAL DISC is the device name listed in this FDA 510(k) record. The listed applicant is Biolife, LLC. It received FDA 510(k) clearance on 2013-07-09 under 510(k) number K130324. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATSEAL DISC?

STATSEAL DISC is a medical device that received FDA 510(k) clearance on 2013-07-09. The listed applicant is Biolife, LLC. The 510(k) number is K130324.

When did STATSEAL DISC receive FDA 510(k) clearance?

STATSEAL DISC received FDA 510(k) clearance on 2013-07-09, under 510(k) number K130324.

Who is the listed applicant for STATSEAL DISC?

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

What is the FDA product code for STATSEAL DISC?

The FDA product code for STATSEAL DISC is QSY.

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Other records listing Biolife, LLC as applicant

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Related Devices (Code: QSY)

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.

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cmSpeciality Fibres and Materials LimitedK250319MFUSE (MS001)Machina Medical, Inc.K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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