Collastat Absorbable Collagen Hemostatic Agent

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Collastat/Instat Absorbable Collagen Hemostatic Agents

Trade Name

Collastat

Generic Name

Agent, absorbable hemostatic, collagen based

PMA Number

P810006 ↗

FDA Product Code

LMF

Device Class

Class III

Regulation

21 CFR Part 878.4490

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S001

• DuraGen® Suturable

  Class III

  CE/MDD

• Mayfield®

  Class I

  CE/MDR

• Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models

  Class II

  FDA 510(k) K140722 Active Cleared 6 Jan 2015

• INTEGRA Wound Matrix (Macro-Channels)

  Unclassified

  FDA 510(k) K210128 Active Cleared 8 Oct 2021

• Mayfield Radiolucent Disposable Skull Pins

  Class II

  FDA 510(k) K071458 Active Cleared 13 Jun 2007

• Licox Pmo Brain Monitoring System

  Class II

  FDA 510(k) K040235 Active Cleared 20 Apr 2004

See all devices from Integra Lifesciences Corporation →

• What types of surgical procedures is the Collastat Absorbable Collagen Hemostatic Agent primarily used for?

  The Collastat Absorbable Collagen Hemostatic Agent is designed for use in general and plastic surgery to promote hemostasis at surgical sites. Its collagen-based matrix helps form a clot, making it particularly useful in procedures where controlling bleeding is critical, such as tissue resections or incisions where traditional methods may be insufficient.

• Is the Collastat Absorbable Collagen Hemostatic Agent reusable, or is it intended for single-use only?

  The Collastat Absorbable Collagen Hemostatic Agent is explicitly supplied in a sterile, single-use form. This ensures patient safety by preventing cross-contamination and maintains the device’s effectiveness, as reuse could compromise sterility and integrity.

• How should the Collastat Absorbable Collagen Hemostatic Agent be stored, and what are the key handling requirements?

  Since it is a sterile medical device, the Collastat Absorbable Collagen Hemostatic Agent must be stored and handled according to standard sterile medical device protocols. This includes keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use to preserve sterility.

• What regulatory pathway does the Collastat Absorbable Collagen Hemostatic Agent follow, and what does this mean for its use?

  The device follows the **FDA_PMA** pathway, granted under PMA number **P810006**, which means it has undergone rigorous pre-market approval to ensure safety and effectiveness. This regulatory route confirms that the product meets stringent standards for use in controlled surgical environments, particularly in general and plastic surgery.

• Are there different sizes or models of the Collastat Absorbable Collagen Hemostatic Agent, and how can I identify them?

  The Collastat Absorbable Collagen Hemostatic Agent comes in multiple product variants, each with distinct registration numbers (e.g., **3011689956**, **1416980**). While the exact sizes or models aren’t detailed in the specifications, these registration numbers likely correspond to different formulations, packaging, or quantities. For precise sizing or model-specific details, refer to the product labeling or consult the manufacturer.