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Micromat W/Various Models

by Pmt, Inc.

510(k) K831117

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831117 Date30 May 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FNW
Device class
Class II
Regulation
21 CFR Part 878.4370
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Micromat with Various Models is a Pad, Kelly, a surgical instrument designed for precise tissue manipulation and dissection. Classified under FDA product code FNW, these devices are intended for general and plastic surgery applications, facilitating controlled handling of soft tissues during operative procedures. The Kelly pad variant is particularly suited for gripping and stabilizing tissue without causing excessive trauma.

Supplied as reusable instruments, the Micromat models are intended for use in sterile surgical environments. They are regulated under FDA 510(k) clearance (K831117) and fall under Class II medical devices, adhering to regulatory standards for surgical instruments. Each model is identified by unique registration numbers (e.g., 9680411, 2182979) and is manufactured by Pmt, Inc. Storage and handling must comply with standard surgical instrument protocols to maintain sterility and functionality.

Other devices from Pmt Corp.

See all devices from Pmt Corp. →

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Micromat Kelly Pad used for in surgical procedures?

    The Micromat Kelly Pad is designed for precise tissue manipulation and dissection, particularly in general and plastic surgery. Its Kelly pad variant is engineered to grip and stabilize soft tissues during operations without causing excessive trauma, ensuring controlled handling for delicate procedures.

  • Are the Micromat Kelly Pads single-use or reusable?

    The Micromat Kelly Pads are reusable surgical instruments. They are intended for use in sterile surgical environments and must be handled and stored according to standard surgical instrument protocols to maintain sterility and functionality.

  • How are the different Micromat models identified?

    Each Micromat model is distinguished by unique registration numbers, such as 9680411, 2182979, 3013006775, and others. These identifiers help differentiate the various models supplied by Pmt, Inc., ensuring proper selection for specific surgical applications.

  • What regulatory clearance does the Micromat Kelly Pad hold?

    The Micromat Kelly Pad holds FDA 510(k) clearance under the reference number K831117. It is classified as a Class II medical device and adheres to regulatory standards for surgical instruments, ensuring compliance with safety and performance requirements.

  • How should Micromat Kelly Pads be stored to maintain functionality?

    Micromat Kelly Pads must be stored and handled in accordance with standard surgical instrument protocols. Proper storage ensures sterility and preserves the instrument’s functionality for repeated use in sterile surgical environments.