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Superstat Absorbable Hemostatic Collagen Agent

by Superstat Corp.

PMA P810040

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

13 closed

Documents

PMA P810040↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP810040 Date22 Feb 1984ApprovedStatusActive

Recalls

13 recalls · FDA

  • 13 recalls, same reason

    • Terminated Z-0336-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0337-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0341-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0331-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0342-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0334-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0343-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0340-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0338-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0333-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0339-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0332-2013 FDA Class II initiated 24 Oct 2012
    • Terminated Z-0335-2013 FDA Class II initiated 24 Oct 2012

    The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Superstat
Generic Name
Agent, absorbable hemostatic, collagen based
PMA Number
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
S005

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an Agent, Absorbable Hemostatic, Collagen Based, classified as a Class III medical device under FDA regulations. It functions as a resorbable hemostatic material designed to control bleeding by promoting clotting through collagen-based absorption, primarily used in surgical procedures within general and plastic surgery.

The Superstat Absorbable Hemostatic Collagen Agent is supplied in sterile form for single-use applications. It is regulated under FDA_PMA with PMA number P810040 and falls under product code LMF (Regulation Number 878.4490). No MRI safety or reusable specifications are indicated in the data, and storage conditions are not detailed beyond standard sterile medical device handling.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the Superstat Absorbable Hemostatic Collagen Agent primarily intended for?

    The Superstat Absorbable Hemostatic Collagen Agent is designed for use in surgical procedures within **general and plastic surgery** to control bleeding. It functions as a resorbable hemostatic material that promotes clotting through collagen-based absorption, making it suitable for applications where precise hemostasis is required.

  • Is the Superstat device single-use or reusable, and how is it supplied?

    The Superstat Absorbable Hemostatic Collagen Agent is **supplied in sterile form for single-use applications only**. This ensures patient safety and maintains the device’s effectiveness, as reusing absorbable hemostatic materials is not recommended due to potential contamination and degradation.

  • What regulatory pathway does the Superstat device follow, and what is its PMA number?

    The Superstat Absorbable Hemostatic Collagen Agent is regulated under the **FDA Pre-Market Approval (PMA) pathway**, which is required for Class III medical devices. Its PMA number is **P810040**, and it falls under product code **LMF (Regulation Number 878.4490)**. This classification reflects its role as a critical hemostatic agent.

  • Are there different sizes or models of the Superstat device, and how would I identify them?

    The Superstat device is available in multiple **FEI (Final Establishment Identification) numbers**, which likely correspond to different lot or batch identifiers rather than distinct physical sizes or models. These numbers (e.g., 3011689956, 1000138054) are used for regulatory tracking and inventory management, not for describing variations in the product’s form or dimensions.

  • How should the Superstat device be stored, and what precautions should be taken?

    While specific storage conditions aren’t detailed in the data, as a **sterile medical device**, the Superstat should be stored according to standard sterile medical device handling guidelines. This typically includes keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use to prevent contamination.