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Haselmeier Pen 8

by Haselmeier GmbH

510(k) K082616

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK082616 Date26 Sep 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
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 Haselmeier Pen 8 is a surgical instrument classified as a pen-type surgical instrument (FDA Product Code: FMF). It is designed for precise cutting, suturing, and tissue manipulation in general surgical procedures, offering ergonomic handling for improved control during operations.

This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K082616) as substantially equivalent to the predicate device, with a special review classification. The Pen 8 is manufactured by Haselmeier GmbH and is intended for use in hospital settings, adhering to standard surgical sterility protocols.

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