# Fms 287305

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/fms-287305>
- Manufacturer: [DePuy Mitek, Inc.](https://devicerts.com/manufacturers/fda-fei-1221934) (United States)
- Name in the registry: FMS 287305
- Device class: Class II (US FDA)
- FDA product code: HRX
- GMDN: Arthroscopic shaver system blade, single-use (41499)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 10886705000333 · listed 2017-03-17 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K954465 · decision 1995-11-09 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0658-2016 · Class II · terminated · initiated 2015-11-20: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- Z-0192-2014 · Class II · terminated · initiated 2013-08-29: Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination

## Identity

- Trade name: FMS [FDA GUDID (AccessGUDID)]
- Generic name: Arthroscopic shaver system blade, single-use [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 287305 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10886705000333 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K954465 [FDA GUDID (AccessGUDID)]
- FDA product code: HRX [FDA GUDID (AccessGUDID)]
- GMDN term: Arthroscopic shaver system blade, single-use (41499) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 888.1100 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Fms 287305, DePuy Mitek, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/fms-287305 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/fms-287305.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/fms-287305
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.