Skip to content

Churchill Lancet

by Churchill Corp.

510(k) K854760

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 · Traditional NumberK854760 Date3 Jan 1986ClearedStatusActive

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  • Withdrawn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)

Full name
Churchhill Lancet
510(k) Number
FDA Product Code
FMK
Device Class
Class II
Regulation
21 CFR Part 878.4850
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

The Churchill Lancet is a medical device classified under the product code FMK. It is substantially equivalent to other devices and has been reviewed by the General, Plastic Surgery advisory committee.

The device is supplied by Churchill Corp. and has been granted FDA 510K authorization. It is associated with the K number K854760 and was cleared on January 3, 1986. The device is intended for use in medical settings, but specific details on its use, sterility, and storage are not provided.

Other devices from Churchill Corp.

See all devices from Churchill Corp. →