Mayfield® 437B1085: FDA 510(k) K081401

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10381780255192 UDI-DI	Date25 Jul 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK081401	Date8 Oct 2008Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK050319	Date31 Mar 2005Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK953124	Date9 Feb 1996Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10381780255192
FDA 510(k) database 510(k) number K081401
FDA 510(k) database 510(k) number K050319
FDA 510(k) database 510(k) number K953124

Across registries

2 registries list this device

FDA 510(k) K081401 decided 8 Oct 2008 Active· +2 more in the status table
FDA GUDID UDI-DI 10381780255192 listed 25 Jul 2016 Listed

Timeline

4 dated events

9 Feb 1996 Cleared FDA 510(k) K953124
31 Mar 2005 Cleared FDA 510(k) K050319
8 Oct 2008 Cleared FDA 510(k) K081401
25 Jul 2016 Listed FDA GUDID 10381780255192

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Mayfield®
Generic name: Skull clamp
Model / reference: 437B1085

Primary DI / UDI-DI: 10381780255192
510(k) Number: K050319
K081401
K953124
FDA product code: HBL
GMDN term: Skull clamp

Device class: Class II
Regulation number: 882.4460
GUDID distribution status: In Commercial Distribution

Category: Skull clamp

Cleared under the same submission (K050319)

and 8 more cleared under K050319

Cleared under the same submission (K081401)

and 8 more cleared under K081401

Similar devices

Also classified as Skull clamp.

DORO® Skull Clamp System 3021-00 — Black Forest Medical GmbH Class II
V. Mueller M-1570 — STERIS CORPORATION Class II
DORO® QR3 Headrest System 1001.100 — Black Forest Medical GmbH Class II
ClearPoint CP-MPHFF-123-01 — Clearpoint Neuro, Inc. Class II
ClearPoint CP-STB-211-01 — Clearpoint Neuro, Inc. Class II

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Other devices filed under Skull clamp.

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Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)