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RESPONDER Polysaccharide Hemostat

FDA 510(k)FDA UDI

U (US FDA 510(k))

510(k) K220525

by Starch Medical, Inc.

Identity

Trade Name
Responder® Polysaccharide Hemostat FDA UDI
Generic Name
Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI
Device Name
RESPONDER® Polysaccharide Hemostat is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. FDA UDI
Model / Reference
RP0010 FDA UDI
Description
RESPONDER® Polysaccharide Hemostat is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. FDA UDI

Identifiers

Primary DI / UDI-DI
00899010002834 FDA UDI
510(k) Number
K220525 FDA 510(k)FDA UDI
FDA Product Code
QSY FDA 510(k)FDA UDI
GMDN Term
Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI

Classification

Device Class
U FDA 510(k)FDA UDI
Advisory Committee
Unknown FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

RESPONDER Polysaccharide Hemostat by Starch Medical, Inc. — U — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Starch Medical, Inc.

Sources (2)

  • FDA 510(k) K220525 24 fields · synced Jun 18, 2026
  • FDA UDI 6baa189e-1bb6-460d-8ad3-cd13c35df356 35 fields · synced May 26, 2026