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FDA 510(k)

ADVANCED TRAUMA DRESSING (ATD)

K-Number: K101257 · 2011-12-01

ApplicantNanosys, Inc.
Decision Date2011-12-01
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

ADVANCED TRAUMA DRESSING (ATD) is the device name listed in this FDA 510(k) record. The listed applicant is Nanosys, Inc.. It received FDA 510(k) clearance on 2011-12-01 under 510(k) number K101257. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCED TRAUMA DRESSING (ATD)?

ADVANCED TRAUMA DRESSING (ATD) is a medical device that received FDA 510(k) clearance on 2011-12-01. The listed applicant is Nanosys, Inc.. The 510(k) number is K101257.

When did ADVANCED TRAUMA DRESSING (ATD) receive FDA 510(k) clearance?

ADVANCED TRAUMA DRESSING (ATD) received FDA 510(k) clearance on 2011-12-01, under 510(k) number K101257.

Who is the listed applicant for ADVANCED TRAUMA DRESSING (ATD)?

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

What is the FDA product code for ADVANCED TRAUMA DRESSING (ATD)?

The FDA product code for ADVANCED TRAUMA DRESSING (ATD) is QSY.

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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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